Trial Outcomes & Findings for Building Evidence for Effective Palliative/End of Life Care for Teens With Cancer (NCT NCT02693665)

NCT ID: NCT02693665

Last Updated: 2025-05-08

Results Overview

Statement of Treatment Preferences documented adolescents' goals of care and families' understanding. Situations were: (1) prolonged hospital stay with ongoing medical intervention and low chance of survival; (2) treatments extend life by no more than 2-3 months with side-effects; (3) physical impairment; and (4) mental impairment. Choices for the four situations were "to continue all treatments …", "to stop all efforts to keep me alive…", or "do not know." Responses for data analysis were recoded into two categories: congruent (family accurately reported what the patient reported as their treatment preference) versus "stop all treatments." Dyadic responses, "do not know" were treated as not congruent and removed from analysis. Percentage dyadic agreement or disagreement was calculated for each situation. Minimum agreement is 0%. Maximum agreement is 100%. Higher percentage dyadic agreement is better outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 260 participants
• Primary outcome timeframe: Agreement on SOTP was assessed 2 weeks post-baseline for controls or immediately following Session 2 for FACE-TC intervention dyads, and at 3, 6, 12 and 18 months.
• Results posted on: 2025-05-08

Participant Flow

There were 260 participants enrolled in the study. Randomization was at the level of the dyad (adolescent with cancer and family surrogate decision maker). After enrollment a secondary screening occurred. 4 participants who were part of an adolescent/family dyad (n=8 participants) failed this secondary screening. Thus, 252 participants (126 adolescent/family dyads) completed the baseline assessment and were then randomized. The flow chart is reported as adolescent/family dyads.

Participant milestones

Measure	FACE-TC Intervention Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Overall Study STARTED	83	43
Overall Study COMPLETED	66	38
Overall Study NOT COMPLETED	17	5

Reasons for withdrawal

Measure	FACE-TC Intervention Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Overall Study Death	3	2
Overall Study Lost to Follow-up	7	3
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	2	0
Overall Study patient wanted to leave it behind	1	0
Overall Study anxiety	1	0
Overall Study family issues	1	0
Overall Study no reason given	1	0

Baseline Characteristics

Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.

Baseline characteristics by cohort

Measure	FACE-TC Intervention n=166 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=86 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.	Total n=252 Participants Total of all reporting groups
Age, Categorical adolescents · <=18 years	44 Participants n=83 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	25 Participants n=43 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	69 Participants n=126 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.
Age, Categorical adolescents · Between 18 and 65 years	39 Participants n=83 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	18 Participants n=43 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	57 Participants n=126 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.
Age, Categorical adolescents · >=65 years	0 Participants n=83 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	0 Participants n=43 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	0 Participants n=126 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.
Age, Categorical family surrogates · <=18 years	0 Participants n=83 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	0 Participants n=43 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	0 Participants n=126 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.
Age, Categorical family surrogates · Between 18 and 65 years	81 Participants n=83 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	43 Participants n=43 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	124 Participants n=126 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.
Age, Categorical family surrogates · >=65 years	2 Participants n=83 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	0 Participants n=43 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.	2 Participants n=126 Participants • Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad.
Age, Continuous Adolescents	16.9 years n=166 Participants	17.0 years n=86 Participants	17 years n=252 Participants
Age, Continuous Family surrogate	45.6 years n=166 Participants	46.5 years n=86 Participants	46 years n=252 Participants
Sex: Female, Male adolescents · Female	45 Participants n=83 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.	27 Participants n=43 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.	72 Participants n=126 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.
Sex: Female, Male adolescents · Male	38 Participants n=83 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.	16 Participants n=43 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.	54 Participants n=126 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.
Sex: Female, Male family surrogates · Female	67 Participants n=83 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.	37 Participants n=43 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.	104 Participants n=126 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.
Sex: Female, Male family surrogates · Male	16 Participants n=83 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.	6 Participants n=43 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.	22 Participants n=126 Participants • Age of adolescents and family surrogate decision makers were used as separate variables in the analysis.
Ethnicity (NIH/OMB) adolescents · Hispanic or Latino	5 Participants n=83 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	0 Participants n=43 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	5 Participants n=126 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.
Ethnicity (NIH/OMB) adolescents · Not Hispanic or Latino	76 Participants n=83 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	40 Participants n=43 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	116 Participants n=126 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.
Ethnicity (NIH/OMB) adolescents · Unknown or Not Reported	2 Participants n=83 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	3 Participants n=43 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	5 Participants n=126 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.
Ethnicity (NIH/OMB) family surrogates · Hispanic or Latino	4 Participants n=83 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	0 Participants n=43 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	4 Participants n=126 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.
Ethnicity (NIH/OMB) family surrogates · Not Hispanic or Latino	79 Participants n=83 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	42 Participants n=43 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	121 Participants n=126 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.
Ethnicity (NIH/OMB) family surrogates · Unknown or Not Reported	0 Participants n=83 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	1 Participants n=43 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.	1 Participants n=126 Participants • Ethnicity was analyzed as a separate variable for adolescents and family surrogates.
Race (NIH/OMB) adolescents · American Indian or Alaska Native	0 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	0 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	0 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) adolescents · Asian	3 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	0 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	3 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) adolescents · Native Hawaiian or Other Pacific Islander	0 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	0 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	0 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) adolescents · Black or African American	12 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	5 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	17 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) adolescents · White	63 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	37 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	100 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) adolescents · More than one race	4 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	1 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	5 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) adolescents · Unknown or Not Reported	1 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	0 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	1 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) family surrogates · American Indian or Alaska Native	0 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	1 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	1 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) family surrogates · Asian	3 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	0 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	3 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) family surrogates · Native Hawaiian or Other Pacific Islander	0 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	0 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	0 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) family surrogates · Black or African American	10 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	4 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	14 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) family surrogates · White	68 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	35 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	103 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) family surrogates · More than one race	2 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	3 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	5 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Race (NIH/OMB) family surrogates · Unknown or Not Reported	0 Participants n=83 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	0 Participants n=43 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.	0 Participants n=126 Participants • Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately.
Region of Enrollment United States	166 participants n=166 Participants	86 participants n=86 Participants	252 participants n=252 Participants
Patient-Reported Outcomes Measures Short Forms pediatric Emotional Distress - Anxiety	13.0 units on a scale n=83 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.	12.0 units on a scale n=43 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.	13.0 units on a scale n=126 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.
Patient-Reported Outcomes Measures Short Forms pediatric Emotional Distress - Depressive Symptoms	10.0 units on a scale n=83 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.	10.0 units on a scale n=43 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.	10.0 units on a scale n=126 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.
Patient-Reported Outcomes Measures Short Forms pediatric Fatigue	16.0 units on a scale n=83 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.	15.0 units on a scale n=43 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.	16.0 units on a scale n=126 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.
Patient-Reported Outcomes Measures Short Forms pediatric Pain Interference	10.0 units on a scale n=83 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.	10.0 units on a scale n=43 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.	10.0 units on a scale n=126 Participants • Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition.
Family Appraisal of Caregiving Questionnaire for Palliative Care Caregiver strain	2.17 units on a scale STANDARD_DEVIATION 0.75 • n=83 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.	2.34 units on a scale STANDARD_DEVIATION 0.89 • n=43 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.	2.23 units on a scale STANDARD_DEVIATION 0.80 • n=126 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.
Family Appraisal of Caregiving Questionnaire for Palliative Care Positive Caregiving Appraisal	4.51 units on a scale STANDARD_DEVIATION 0.46 • n=83 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.	4.61 units on a scale STANDARD_DEVIATION 0.40 • n=43 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.	4.54 units on a scale STANDARD_DEVIATION 0.44 • n=126 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.
Family Appraisal of Caregiving Questionnaire for Palliative Care Caregiver distress	2.19 units on a scale STANDARD_DEVIATION 0.78 • n=83 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.	2.44 units on a scale STANDARD_DEVIATION 0.80 • n=43 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.	2.28 units on a scale STANDARD_DEVIATION 0.79 • n=126 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.
Family Appraisal of Caregiving Questionnaire for Palliative Care Family well-being	4.13 units on a scale STANDARD_DEVIATION 0.67 • n=83 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.	4.25 units on a scale STANDARD_DEVIATION 0.63 • n=43 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.	4.17 units on a scale STANDARD_DEVIATION 0.66 • n=126 Participants • Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment.
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded Adolescent Meaning/Peace	28.0 units on a scale n=83 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	26.0 units on a scale n=43 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	28.0 units on a scale n=126 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded Adolescent Faith	12.0 units on a scale n=83 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	14.0 units on a scale n=43 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	12.5 units on a scale n=126 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded Adolescent Total score	78.0 units on a scale n=83 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	75.0 units on a scale n=43 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	77.0 units on a scale n=126 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded Family Meaning/Peace	28.0 units on a scale n=83 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	29.0 units on a scale n=43 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	28.0 units on a scale n=126 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded Family Faith	13.0 units on a scale n=83 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	15.0 units on a scale n=43 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	14.0 units on a scale n=126 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded Family Total score	79.0 units on a scale n=83 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	85.0 units on a scale n=43 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.	80.5 units on a scale n=126 Participants • Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit.

PRIMARY outcome

Timeframe: Agreement on SOTP was assessed 2 weeks post-baseline for controls or immediately following Session 2 for FACE-TC intervention dyads, and at 3, 6, 12 and 18 months.

Population: Total number for overall congruence of Statement of Treatment Preferences 2-weeks post baseline or post-Session 2 (n=115 dyads). Data were analyzed and are presented at the level of dyadic congruence, i.e. 73 dyads (146 adolescent and family participants) in the intervention arm and 42 dyads (84 participants) in the control arm. 1 dyad (2 participants) had missing data.

Statement of Treatment Preferences documented adolescents' goals of care and families' understanding. Situations were: (1) prolonged hospital stay with ongoing medical intervention and low chance of survival; (2) treatments extend life by no more than 2-3 months with side-effects; (3) physical impairment; and (4) mental impairment. Choices for the four situations were "to continue all treatments …", "to stop all efforts to keep me alive…", or "do not know." Responses for data analysis were recoded into two categories: congruent (family accurately reported what the patient reported as their treatment preference) versus "stop all treatments." Dyadic responses, "do not know" were treated as not congruent and removed from analysis. Percentage dyadic agreement or disagreement was calculated for each situation. Minimum agreement is 0%. Maximum agreement is 100%. Higher percentage dyadic agreement is better outcome.

Outcome measures

Measure	FACE-TC Intervention n=73 Dyads Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=42 Dyads Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care. Immediately post-session 2 · Poor Agreement: Agree 0-1 situation	10 Dyads	22 Dyads
Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care. Immediately post-session 2 · Moderate Agreement: Agree 2-3 situations	38 Dyads	19 Dyads
Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care. Immediately post-session 2 · Perfect agreement: agree all 4 situations	25 Dyads	1 Dyads
Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care. 3 Months post-intervention · Poor Agreement: Agree 0-1 situation	23 Dyads	12 Dyads
Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care. 3 Months post-intervention · Moderate Agreement: Agree 2-3 situations	37 Dyads	19 Dyads
Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care. 3 Months post-intervention · Perfect agreement: agree all 4 situations	5 Dyads	6 Dyads

SECONDARY outcome

Timeframe: Change from baseline in quality of life (defined as symptoms of anxiety, depression, fatigue and pain interference) at 3, 6, and 12 months post baseline compared to controls

Population: Adolescents living with cancer. Higher scores indicate worse symptoms of anxiety, depressive symptoms, fatigue and pain interference. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits, attrition, or deaths at 3-months, 6-months, and 12-months. Changes in number of participants reflects missing visits, deaths, or attrition.

Assessed adolescent Emotional distress-Anxiety; Emotional Distress-Depressive Symptoms; Fatigue; and Pain Interference using these PROMIS subscales. Each subscale has 8 items each. Minimum value is 8. Maximum value is 40. Higher scores mean worse outcomes for anxiety, depressive symptoms, fatigue, and pain interference.

Outcome measures

Measure	FACE-TC Intervention n=83 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=43 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Emotional Distress-Anxiety baseline	13.0 raw score units on a scale Interval 10.0 to 16.5	12.0 raw score units on a scale Interval 9.0 to 18.0
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Emotional Distress -Depressive Symptoms symptoms baseline	10.0 raw score units on a scale Interval 8.0 to 16.0	10.0 raw score units on a scale Interval 8.0 to 13.5
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Fatigue baseline	16.0 raw score units on a scale Interval 11.0 to 23.0	15.0 raw score units on a scale Interval 12.0 to 22.5
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Pain Interference baseline	10.0 raw score units on a scale Interval 8.0 to 16.0	10.0 raw score units on a scale Interval 8.0 to 20.5
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Emotional Distress Anxiety 3 months	17 raw score units on a scale Interval 12.0 to 22.0	12.5 raw score units on a scale Interval 10.0 to 20.0
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Emotional Distress Depressive Symptoms 3 Months	13.0 raw score units on a scale Interval 8.0 to 21.0	11.0 raw score units on a scale Interval 8.0 to 18.5
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Fatigue 3 months	18 raw score units on a scale Interval 12.0 to 31.0	14.0 raw score units on a scale Interval 10.0 to 21.0
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Pain Interference 3 months	12.0 raw score units on a scale Interval 8.0 to 21.0	10.5 raw score units on a scale Interval 8.0 to 16.0
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Emotional distress - anxiety 6 months	16.0 raw score units on a scale Interval 12.0 to 21.0	14.0 raw score units on a scale Interval 11.0 to 21.0
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Emotional distress - depressive symptoms 6 months	13.0 raw score units on a scale Interval 8.0 to 19.0	10.0 raw score units on a scale Interval 8.0 to 15.0
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Fatigue 6 months	16.0 raw score units on a scale Interval 11.0 to 29.0	16.0 raw score units on a scale Interval 11.0 to 25.0
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Pain Interference 6 months	11.0 raw score units on a scale Interval 8.0 to 19.0	9.0 raw score units on a scale Interval 8.0 to 15.0
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Emotional distress - anxiety 12 months	17.0 raw score units on a scale Interval 11.0 to 22.0	11.0 raw score units on a scale Interval 8.8 to 18.0
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Emotional distress - depression	12.0 raw score units on a scale Interval 9.0 to 19.3	10.0 raw score units on a scale Interval 8.0 to 13.3
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Fatigue - 12 months	17.0 raw score units on a scale Interval 10.0 to 27.0	12.5 raw score units on a scale Interval 10.0 to 21.3
Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. Pain Interference - 12 months	10.5 raw score units on a scale Interval 8.0 to 18.0	8.0 raw score units on a scale Interval 8.0 to 12.0

SECONDARY outcome

Timeframe: Controlling for baseline, change in of meaning and peace subscale and faith subscale at 3, 6, 12 months post intervention for intervention adolescents compared to control adolescents. Total scores provided for interested investigators were not outcome.

Population: Adolescents living with cancer. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due to missed study visits, attrition, or deaths at 3-months, 6-months, and 12-months. There are no missing data.

Assessed construct of spiritual well-being. Two subscales Meaning/Peace (7 items) and Faith (5 items) and Total score (12 items) were calculated. on a 5-point Likert scale from 0=not at all to 5=very much. Some items are reverse scored. See www.facit.org Meaning/Peace subscale score range from minimum value of 0 to maximum value of 32. Higher scores indicate better meaning/peace.

Faith subscale score range from 0 minimum value to maximum value of 16. Higher scores indicate better meaning/peace.

Total score range is from 0 minimum value to maximum value of 92. Higher scores indicate better spiritual well-being.

Outcome measures

Measure	FACE-TC Intervention n=83 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=43 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) FACIT-Sp v4 Total score 6 months	76.0 units on a scale Interval 64.0 to 83.0	77.0 units on a scale Interval 61.0 to 84.0
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) Meaning and Peace subscale baseline	28.0 units on a scale Interval 25.0 to 30.0	26.0 units on a scale Interval 23.5 to 29.0
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) Faith subscale baseline	12.0 units on a scale Interval 9.0 to 15.5	14.0 units on a scale Interval 9.0 to 15.5
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) Total FACIT-SP vs. 4 score baseline	78 units on a scale Interval 69.5 to 85.5	75.0 units on a scale Interval 69.0 to 82.0
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) Meaning and Peace subscale 3 months	26.0 units on a scale Interval 23.0 to 30.0	27.5 units on a scale Interval 22.3 to 29.0
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) Faith subscale 3 months	12.0 units on a scale Interval 8.0 to 15.0	12.0 units on a scale Interval 9.3 to 15.0
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) FACIT-SP vs4 Total Score 3 months	72.0 units on a scale Interval 65.0 to 84.0	75.0 units on a scale Interval 66.0 to 86.0
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) Meaning and Peace subscale 6 months	26.0 units on a scale Interval 24.0 to 30.0	27.0 units on a scale Interval 24.0 to 31.0
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) Faith subscale 6 months	12.0 units on a scale Interval 6.0 to 15.0	12.0 units on a scale Interval 7.0 to 15.0
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) Meaning and Peace subscale 12 month	26.0 units on a scale Interval 23.0 to 30.0	29.5 units on a scale Interval 25.0 to 32.0
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) Faith subscale 12 months	11.0 units on a scale Interval 8.0 to 16.0	12.0 units on a scale Interval 8.0 to 16.0
Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) FACIT-SP v4 Total 12 months	71 units on a scale Interval 62.0 to 82.0	80.5 units on a scale Interval 68.8 to 88.0

SECONDARY outcome

Timeframe: Baseline and 3 months post baseline administered to family surrogates only.

Population: Data were analyzed for family surrogate only. 83 surrogates randomized to FACE TC and 43 surrogates randomized to TAU at baseline. At 3 months post-intervention analyzed population was 65 FACE-TC and 37 TAU. One TAU surrogate missed this study visit at 3 months post intervention. Changes in number of participants reflect missed study visits, deaths, or loss to follow-up.

The FACQ-PC is a 25-item measure consists of four theoretically derived subscales: (i) caregiver strain, (ii) positive caregiving appraisals, (iii) caregiver distress, and (iv) family well-being. Scores are from 5 = strongly agree to 1 = strongly disagree. We did not calculate a Total score. We only used the 4 subscale scores. On the subscale scores for positive caregiving appraisals and family well-being, higher scores mean better outcomes, i.e. greater positive caregiving appraisals or family well-being. On the subscale scores for caregiver strain and caregiver distress, higher scores mean worse outcomes, i.e. greater caregiver strain or caregiver distress. The FACQ-PC subscale scores were computed by taking the mean of the items (score range 1-5). Some items were reverse scored, depending on how the item is phrased, so that higher scores = higher amount of the subscale being measured. So the minimum value for each subscale is 1 and the maximum value for each subscale is 5.

Outcome measures

Measure	FACE-TC Intervention n=83 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=43 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Caregiver strain Baseline	2.17 units on a scale Standard Deviation 0.75	2.34 units on a scale Standard Deviation 0.89
Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Positive Caregiving Appraisal Baseline	4.51 units on a scale Standard Deviation 0.46	4.61 units on a scale Standard Deviation 0.40
Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Caregiver distress Baseline	2.19 units on a scale Standard Deviation 0.78	2.44 units on a scale Standard Deviation 0.80
Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Family Wellbeing (Higher score=better wellbeing)	4.13 units on a scale Standard Deviation 0.67	4.25 units on a scale Standard Deviation 0.63
Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Caregiver strain 3 months	2.15 units on a scale Standard Deviation 0.81	2.39 units on a scale Standard Deviation 0.81
Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Positive caregiving appraisal 3 months	4.55 units on a scale Standard Deviation 0.45	4.47 units on a scale Standard Deviation 0.54
Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Caregiver distress 3 months	2.23 units on a scale Standard Deviation 0.90	2.49 units on a scale Standard Deviation 1.01
Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) Family well-being 3 months	4.12 units on a scale Standard Deviation 0.70	4.09 units on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: This adolescent outcome was measured at one time point only, between 18 months post-intervention or study close-out. At study close out we had 117 adolescents in the study. Attrition was due to deaths, lost to follow-up, and withdrawals.

Population: Adolescent data only on documentation of an advance directive in the electronic health.

The effect of the intervention on documentation in the Electronic Health Record of any advance directive for the adolescent was conducted at study close, using a standardized chart abstraction form.

Outcome measures

Measure	FACE-TC Intervention n=75 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=42 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Advance Directive for Adolescent Only Located in the Electronic Health Record at Study Close Out. Any advance directive, yes	60 Participants	8 Participants
Advance Directive for Adolescent Only Located in the Electronic Health Record at Study Close Out. Any advance directive, no	15 Participants	34 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 234 participants completed this assessment at two weeks post-baseline for control; two weeks post-baseline for intervention--immediately following Session 2. This process assessment is not in the flow diagram because it is not an intervention outcome.

Population: Participants (adolescents with cancer and their family surrogate decision-maker) ratings of quality of communication with facilitator. Separate analysis were conducted for adolescents and their family surrogate, i.e. analysis was not at the level of the dyad. Changes in participants over time reflect missed study visits, deaths, or loss to follow-up.

Curtis's Quality of Participant-Interviewer Communication Questionnaire (Curtis et al 1999) evaluated quality of communication that occurred between participants and facilitator. The first 4 items are: 1. Do you think that your attitudes are known by the interviewer? 2. Did you feel that the interviewer cared about you as a person? 3. Did you feel that the interviewer listened to what you said? 4. Did you feel that the interviewer gave you enough attention? 5-point Likert scale ranging from Probably no to probably yes.

The 5th item is: How would you rate the overall quality of the discussions you just had with the interviewer? Range of scores is from 5 to 25. Higher scores indicate higher quality of communication.

Outcome measures

Measure	FACE-TC Intervention n=150 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=84 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Quality of End of Life Communication (QOC) Adolescent ratings	22.3 units on a scale Standard Deviation 3.2	22.1 units on a scale Standard Deviation 2.4
Quality of End of Life Communication (QOC) Family member ratings	23.4 units on a scale Standard Deviation 1.8	22.4 units on a scale Standard Deviation 2.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline and at 3, 6, and 12 months post-intervention.

Population: Adolescents with cancer responses at baseline, 3, 6 and 12 months post-intervention.

Responses to "How often do you go to religious services? Responses ranged from "more than once a week" to "once or twice a year." Higher scores indicated greater attendance at religious services. Responses were used as a covariate in the initial Generalized linear mixed effect models. Prior research had indicated that this variable moderated quality of life outcomes.

Outcome measures

Measure	FACE-TC Intervention n=83 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=43 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Declined	2 Participants	1 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Every month or so	6 Participants	5 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Every week or more often	20 Participants	10 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · More than once a week	8 Participants	3 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Never	13 Participants	9 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Once or twice a month	21 Participants	9 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Once or twice a year	13 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Missing	0 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Declined	1 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Every month or so	2 Participants	4 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Every week or more often	16 Participants	9 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · More than once a week	8 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Never	11 Participants	9 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Once or twice a month	16 Participants	11 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Once or twice a year	11 Participants	3 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Missing	2 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Declined	0 Participants	1 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Every month or so	5 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Every week or more often	19 Participants	8 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · More than once a week	6 Participants	4 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Never	12 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Once or twice a month	13 Participants	8 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Once or twice a year	10 Participants	8 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Missing	2 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Declined	0 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Every month or so	8 Participants	4 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Every week or more often	18 Participants	8 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · More than once a week	5 Participants	5 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Never	7 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Once or twice a month	9 Participants	5 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Once or twice a year	13 Participants	8 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Missing	6 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline in religiousness/spirituality at 3, 6, and 12 months post baseline compared to controls

Population: Adolescents with cancer responses at baseline, 3, 6 and 12 months post-intervention.

Responses to "To what extent do you consider yourself a religious person? Responses ranged from "not religious at all" to "very religious." Higher scores indicated greater religiousness.

Responses were used as a covariate in the initial Generalized linear mixed effect models.

Prior research indicated that this item was associated with quality of life outcomes.

Outcome measures

Measure	FACE-TC Intervention n=83 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=43 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Moderately religious	34 Participants	22 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Not religious at all	16 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Slightly religious	23 Participants	9 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Very religious	10 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Declined	0 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · missing	0 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Moderately religious	30 Participants	17 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Not religious at all	15 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Slightly religious	14 Participants	10 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Very religious	6 Participants	4 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Declined	0 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · missing	2 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Moderately religious	31 Participants	15 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Not religious at all	18 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Slightly religious	10 Participants	15 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Very religious	5 Participants	4 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Declined	1 Participants	1 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · missing	2 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Moderately religious	26 Participants	14 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Not religious at all	15 Participants	8 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Slightly religious	13 Participants	12 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Very religious	6 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Declined	1 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · missing	5 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline in religiousness/spirituality at 3, 6, and 12 months post-intervention. Used as a covariate in generalized linear mixed effect models.

Population: Adolescents with cancer responses at baseline, 3, 6 and 12 months post-intervention.

Responses to "To What Extent do You Consider Yourself a spiritual person?" Responses ranged from "not spiritual at all" to "very spiritual." Higher score meant more spiritual. Reported are frequency distributions and percentages.

Outcome measures

Measure	FACE-TC Intervention n=83 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=43 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Moderately spiritual	27 Participants	10 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Moderately spiritual	27 Participants	17 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Not spiritual at all	6 Participants	8 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Slightly spiritual	32 Participants	12 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Very spiritual	18 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Declined	0 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Missing	0 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Moderately spiritual	29 Participants	10 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Not spiritual at all	8 Participants	5 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Slightly spiritual	14 Participants	16 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Very spiritual	14 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Declined	0 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Missing	2 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Moderately spiritual	23 Participants	11 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Not spiritual at all	8 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Slightly spiritual	24 Participants	19 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Very spiritual	9 Participants	4 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Declined	1 Participants	1 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Missing	2 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Not spiritual at all	8 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Slightly spiritual	16 Participants	16 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Very spiritual	8 Participants	3 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Declined	2 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Missing	5 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline in religiousness/spirituality at 3, 6, and 12 months post baseline compared to controls for adolescents only.

Population: Adolescents living with cancer Higher scores indicate increased frequency of experience or behavior. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits, attrition, or deaths at 3-months, 6-months, and 12-months.

Responses to "How often do you pray privately?" Frequency of behavior was surveyed. Responses ranged from never to a few times a week. Higher scores indicated more praying privately.

5 items were used in this study based on previous research with adolescent populations, which showed that these 5 items moderated study outcomes.

Responses were used as covariates in the initial modeling.

Outcome measures

Measure	FACE-TC Intervention n=83 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=43 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately?. Baseline. · A few times a month	6 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately?. Baseline. · A few times a week	25 Participants	9 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately?. Baseline. · Declined	1 Participants	1 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately?. Baseline. · Less than once a month	6 Participants	3 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately?. Baseline. · More than once a day	9 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately?. Baseline. · Never	17 Participants	4 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately?. Baseline. · Once a day	11 Participants	10 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately?. Baseline. · Once a month	4 Participants	1 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately?. Baseline. · Once a week	4 Participants	1 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately?. Baseline. · Missing	0 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months. · A few times a month	7 Participants	1 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months. · A few times a week	15 Participants	5 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months. · Declined	1 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months. · Less than once a month	8 Participants	5 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months. · More than once a day	8 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months. · Never	10 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months. · Once a day	10 Participants	11 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months. · Once a month	1 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months. · Once a week	5 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months. · Missing	2 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 6 months. · A few times a month	5 Participants	3 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 6 months. · A few times a week	10 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 6 months. · Declined	1 Participants	1 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 6 months. · Less than once a month	6 Participants	3 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 6 months. · More than once a day	9 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 6 months. · Never	14 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 6 months. · Once a day	14 Participants	10 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 6 months. · Once a month	2 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 6 months. · Once a week	4 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 6 months. · Missing	2 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 12 months. · A few times a month	6 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 12 months. · A few times a week	10 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 12 months. · Declined	1 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 12 months. · Less than once a month	5 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 12 months. · More than once a day	11 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 12 months. · Never	11 Participants	8 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 12 months. · Once a day	11 Participants	5 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 12 months. · Once a month	3 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 12 months. · Once a week	3 Participants	4 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) How often do you pray privately. 12 months. · Missing	5 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline in religiousness/spirituality and at 3, 6, and 12 months post baseline compared to controls. Responses were used as a covariate in the initial generalized linear mixed effect models.

Population: Adolescents living with cancer.

Responses to item "I feel God's presence". Responses range from never to many times a day. Higher scores indicated greater experience of feeling God's presence.

Prior research had demonstrated this item moderated study outcomes with respect to quality of life outcomes.

Outcome measures

Measure	FACE-TC Intervention n=83 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=43 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Declined	2 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Every day	13 Participants	10 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Many times a day	10 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Most days	20 Participants	10 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Never or almost never	18 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Once in a while	11 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Some days	9 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) Baseline · Missing	0 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Declined	3 Participants	1 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Every day	15 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Many times a day	8 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Most days	11 Participants	10 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Never or almost never	9 Participants	4 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Once in a while	9 Participants	5 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Some days	10 Participants	5 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 3 months · Missing	2 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Declined	1 Participants	2 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Every day	15 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Many times a day	9 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Most days	10 Participants	13 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Never or almost never	10 Participants	5 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Once in a while	11 Participants	5 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Some days	9 Participants	4 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 6 months · Missing	2 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Declined	1 Participants	0 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Every day	11 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Many times a day	9 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Most days	15 Participants	7 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Never or almost never	12 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Once in a while	4 Participants	6 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Some days	9 Participants	3 Participants
Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) 12 months · Missing	5 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Two weeks post-baseline for control; two weeks post-baseline for intervention--immediately following Session 2. This was a process measure and as such is not reflected in the flow diagram, as it was not a primary or secondary outcome.

Population: Adolescents with cancer and their family surrogate decision makers responding agree or strongly agree to each item.

Items for this 13-item assessment of adolescent and family satisfaction with the FACE-TC intervention were developed using input from the community about the emotional of participation. Items are on a 5-point Likert scale from strongly disagree to strongly agree. 6 items were negative (felt afraid, too much to handle, harmful, angry, sad hurtful) and 7 items were positive (useful, helpful, load off my mind, satisfied, something I needed to do, courageous, worthwhile). Each subscale was scored separately. The minimum positive score was 17 and the maximum positive score was 35 for adolescents. The minimum negative score was 6 and the maximum negative score was 22 for adolescents. The minimum positive score was 11 and maximum score was 35 for family surrogate. The minimum negative score was 6 and the maximum negative score was 23 for surrogates. Higher score for positive scale was better outcome. Higher score for negative scale was worse outcome.

Outcome measures

Measure	FACE-TC Intervention n=150 Participants Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent \& Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.	Treatment As Usual (TAU) n=84 Participants Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention.
Satisfaction Questionnaire Adolescents positive score	26.8 score on a scale Standard Deviation 3.6	26.4 score on a scale Standard Deviation 3.8
Satisfaction Questionnaire Adolescent negative score	11.2 score on a scale Standard Deviation 3.8	10.1 score on a scale Standard Deviation 3.2
Satisfaction Questionnaire Family surrogate positive score	28.1 score on a scale Standard Deviation 3.3	24.9 score on a scale Standard Deviation 4.4
Satisfaction Questionnaire Family surrogate negative score	11.4 score on a scale Standard Deviation 4.0	12.4 score on a scale Standard Deviation 4.1

Adverse Events

FACE-TC Intervention Adolescent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Treatment As Usual (TAU) Adolescent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

FACE-TC Intervention Family Member

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

TAU Family Member

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Maureen E. Lyon, PhD, Professor of Pediatrics, Principal Investigator

Children's National Medical Center

Phone: 703-346-2873

Email: mlyon@childrensnational.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place