Trial Outcomes & Findings for Feasibility of a Self-Management + Peer Mentoring Intervention for Adolescent and Young Adult Childhood Cancer Survivors (NCT NCT04075734)

NCT ID: NCT04075734

Last Updated: 2022-05-31

Results Overview

Determined by number of eligible patients consented and completing baseline. Hypothesis: \>50% of eligible will consent and complete the baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2022-05-31

Participant Flow

Participant milestones

Measure	Intervention The intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks. Managing Your Health: Self-Management + Peer Mentoring: The online educational component consists of 5 self-management educational modules: (1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy. Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call.	Usual Care Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.	Mentors Peer Mentors were recruited and matched 1:1 with each participant randomized to Intervention to facilitate engagement with the online modules and offer specialized support.
Overall Study STARTED	25	25	10
Overall Study COMPLETED	21	24	10
Overall Study NOT COMPLETED	4	1	0

Reasons for withdrawal

Measure	Intervention The intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks. Managing Your Health: Self-Management + Peer Mentoring: The online educational component consists of 5 self-management educational modules: (1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy. Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call.	Usual Care Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.	Mentors Peer Mentors were recruited and matched 1:1 with each participant randomized to Intervention to facilitate engagement with the online modules and offer specialized support.
Overall Study Lost to Follow-up	1	1	0
Overall Study Withdrawal by Subject	3	0	0

Baseline Characteristics

Feasibility of a Self-Management + Peer Mentoring Intervention for Adolescent and Young Adult Childhood Cancer Survivors

Baseline characteristics by cohort

Measure	RCT Intervention n=25 Participants The intervention consists of (1) online self-management educational modules and (2) weekly peer mentor calls to facilitate engagement with the modules and offer specialized support over approximately six weeks. Managing Your Health: Self-Management + Peer Mentoring: The online educational component consists of 5 self-management educational modules: (1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy. Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call.	RCT Usual Care n=25 Participants Participants receive usual care.	Mentors n=10 Participants Peer Mentors were recruited and matched 1:1 with each participant randomized to RCT Intervention to facilitate engagement with the online modules and offer specialized support.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	10 Participants n=5 Participants	60 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	21.12 years STANDARD_DEVIATION 2.03 • n=5 Participants	21.60 years STANDARD_DEVIATION 1.89 • n=7 Participants	26.50 years STANDARD_DEVIATION 2.46 • n=5 Participants	23.07 years STANDARD_DEVIATION 2.13 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	16 Participants n=7 Participants	5 Participants n=5 Participants	35 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	24 Participants n=7 Participants	10 Participants n=5 Participants	55 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	14 Participants n=7 Participants	9 Participants n=5 Participants	39 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	10 participants n=5 Participants	60 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All potentially eligible participants identified by the New Jersey State Cancer Registry (NJSCR) and approached at the local Long-Term Information Treatment Evaluation (LITE) program by study staff.

Determined by number of eligible patients consented and completing baseline. Hypothesis: >50% of eligible will consent and complete the baseline.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=79 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Feasibility Measure: Enrollment (Young Adult Survivors) - Number of Eligible Patients Consented and Completing Baseline Enrolled	50 Participants	—
Feasibility Measure: Enrollment (Young Adult Survivors) - Number of Eligible Patients Consented and Completing Baseline Not Interested	29 Participants	—

PRIMARY outcome

Timeframe: Time 3 at about 5 months since Baseline.

Population: Young Adult Survivors who enrolled on study, i.e., consented and completed baseline.

Retention in study (Young Adult Survivors). Determined by the percent of consented patients who are retained in the study and complete Time 3 follow-up. Hypothesis: >80%.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Feasibility Measure: Retention in Study (Young Adult Survivors): Percent of Consented Patients Who Are Retained in the Study and Complete Time 3 Follow-up	22 Participants	25 Participants

PRIMARY outcome

Timeframe: Time 2, about 2 months since baseline.

Population: Data available and reported only for participants who were assigned to this group and completed the tested intervention, i.e., n=22. Total of three participants assigned to this group, withdrew from the study, without completing the tested intervention.

Mean percent completed per task: (a) On-line self-management educational modules and (b) Weekly calls with peer mentor.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=22 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Feasibility: Completion of the Intervention (Young Adult Survivors): Percentage On-line self-management educational modules	95.72 percent completed Interval 58.8 to 100.0	—
Feasibility: Completion of the Intervention (Young Adult Survivors): Percentage Weekly calls with peer mentor	97.72 percent completed Interval 66.7 to 100.0	—

PRIMARY outcome

Timeframe: Time 2, about 2 months since baseline.

Population: Data available and reported only for participants who were assigned to this group and completed the tested intervention, i.e., n=22. Total of three participants assigned to this group, withdrew from the study, without completing the tested intervention.

Five items assess satisfaction with each aspect of the intervention: a. Overall program satisfaction; b. Content of online modules; c. Discussions with peer mentor; d. Frequency of calls with peer mentor; and e. Duration of program. First 3 items (a, b and c) were evaluated using a 5-point scale, (Minimum 1, Maximum 5) with higher scores indicating greater satisfaction. Item c evaluated on a scale from 1 "not frequent enough" to 3 "too frequent". Item d uses a 1 "way too short" to 5 "way too long" scale. The sample mean will be examined.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=22 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean a. Satisfaction w/ Program overall [Scale 1-5]	4.64 score on a scale Standard Deviation 0.49	—
Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean b. Satisfaction w/ Content of online modules [Scale 1-5]	4.41 score on a scale Standard Deviation 0.59	—
Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean c. Satisfaction w/ Discussions with peer mentor [Scale 1-5]	4.64 score on a scale Standard Deviation 0.49	—
Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean d. Satisfaction w/ Frequency of calls with peer mentor [Scale 1-3; 2="Just right"]	2.00 score on a scale Standard Deviation 0.31	—
Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean e. Satisfaction w/ Duration of program [Scale 1-5; 3= "Just right"	2.86 score on a scale Standard Deviation 0.47	—

PRIMARY outcome

Timeframe: Time 2, about 2 months since baseline.

Population: Data available and reported only for participants who were assigned to this group and completed the tested intervention, i.e., n=22. Total of three participants assigned to this group, withdrew from the study, without completing the tested intervention.

The Utility Questionnaire is an 11-item scale that measures perceived ease of use and convenience of the online program using a 5-point scale, (minimum 1, maximum 5) with higher scores indicating greater perceived utility. An overall mean of all items will be calculated.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=22 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Feasibility: Utility of the Online Self-Management Modules (Young Adult Survivors): Questionnaire	4.35 score on a scale Standard Deviation 0.54	—

PRIMARY outcome

Timeframe: Time 2, about 2 months since baseline.

Population: Data available and reported only for participants who were assigned to this group and completed the tested intervention, i.e., n=22. Total of three participants assigned to this group, withdrew from the study, without completing the tested intervention.

The Impact Questionnaire is a 13-item scale that measures perceived effectiveness of the online program using a 5-point scale, (minimum 1, and maximum 5) with higher scores indicating greater perceived effectiveness. An overall mean of all items will be calculated.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=22 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Feasibility: Impact of the Online Self-Management Modules (Young Adult Survivors): Questionnaire	4.29 score on a scale Standard Deviation 0.48	—

PRIMARY outcome

Timeframe: Time 2, about 2 months since baseline.

Population: Data available and reported only for participants who were assigned to this group and completed the tested intervention, i.e., n=22. Total of three participants assigned to this group, withdrew from the study, without completing the tested intervention.

The Adherence Barriers Questionnaire is a 6-item scale that measures perceived barriers to using the online program using a 5-point scale, (minimum 1 and maximum 5) with higher scores indicating greater perceived barriers. An overall mean of all items will be calculated.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=22 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Feasibility: Adherence Barriers to the Online Self-Management Modules (Young Adult Survivors): Questionnaire	1.17 score on a scale Standard Deviation 0.24	—

PRIMARY outcome

Timeframe: Time 2, about 2 months since baseline

Population: Peer mentors and young adult survivors in RCT Intervention group who completed the tested intervention (i.e., n=22). Please note, while total number of mentors on study was n=10, total reports by mentors for this measure was n=22 (some mentors were assigned to mentor more than one young adult survivor assigned to RCT intervention group.)

Acceptance will be evaluated by young adult survivors' and peer mentors' report on perceived alliance with each other using the Working Alliance Inventory - Short Form Revised (Hatcher & Gillaspy, 2006), a validated measure of the quality and strength of the relationship. Items are rated on a 5-point scale. The measure yields 3 subscales summary scores that can range from 5 to 20, with higher scores indicating more positive relationships. Sum scores on each sub-scale with be calculated: Bond, Goal, and Task.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=22 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=10 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Acceptance of Peer Mentors (Young Adult Survivors and Peer Mentors): Questionnaire Bond	18.41 score on a scale Standard Deviation 1.92	19.55 score on a scale Standard Deviation 1.14
Acceptance of Peer Mentors (Young Adult Survivors and Peer Mentors): Questionnaire Goal	17.68 score on a scale Standard Deviation 2.28	13.45 score on a scale Standard Deviation 1.71
Acceptance of Peer Mentors (Young Adult Survivors and Peer Mentors): Questionnaire Task	18.14 score on a scale Standard Deviation 2.01	13.09 score on a scale Standard Deviation 1.66

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

The Readiness for Transition Questionnaire - Survivor Version (RTQ) assesses the degree to which survivors are responsible for 10 healthcare behaviors, including knowing their survivorship care plan, scheduling annual visits, scheduling specialist appointments, taking and filling medications (if prescribed), explaining medical history to others, knowing insurance coverage, attending appointments, communicating with providers, and calling providers, on a 4-point scale, with higher scores indicating higher levels of responsibility. The RTQ yields a total mean score for responsibility. It also has one item evaluating "overall readiness to assume complete responsibility for healthcare" with response options of Not at all ready, somewhat ready, mostly ready, or completely ready. The sample mean for the Total Responsibility score and overall readiness item will be calculated (range 1-4)

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Healthcare Responsibility (Young Adult Survivors) Time 3 RTQ Overall readiness	2.86 score on a scale Standard Deviation 0.77	2.8 score on a scale Standard Deviation 0.91
Healthcare Responsibility (Young Adult Survivors) Time 4 RTQ Overall readiness	3.14 score on a scale Standard Deviation 0.79	3.04 score on a scale Standard Deviation 0.95
Healthcare Responsibility (Young Adult Survivors) Baseline RTQ Total	2.73 score on a scale Standard Deviation 0.63	2.83 score on a scale Standard Deviation 0.54
Healthcare Responsibility (Young Adult Survivors) Time 2 RTQ Total	3.1 score on a scale Standard Deviation 0.67	3.08 score on a scale Standard Deviation 0.49
Healthcare Responsibility (Young Adult Survivors) Time 3 RTQ Total	3.02 score on a scale Standard Deviation 0.72	3.07 score on a scale Standard Deviation 0.64
Healthcare Responsibility (Young Adult Survivors) Time 4 RTQ Total	3.16 score on a scale Standard Deviation 0.64	3.23 score on a scale Standard Deviation 0.63
Healthcare Responsibility (Young Adult Survivors) Baseline RTQ Overall readiness	2.36 score on a scale Standard Deviation 0.76	2.8 score on a scale Standard Deviation 0.96
Healthcare Responsibility (Young Adult Survivors) Time 2 RTQ Overall readiness	2.64 score on a scale Standard Deviation 0.85	2.76 score on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

The knowledge subscale from the Transition Readiness Inventory (TRI) measures knowledge of survivorship care using a 5-point scale, with higher scores indicating greater knowledge. A mean score will be calculated (range 1-5).

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Knowledge (Young Adult Survivors) Time 3	4.4 score on a scale Standard Deviation 0.7	4.45 score on a scale Standard Deviation 0.77
Knowledge (Young Adult Survivors) Baseline	3.44 score on a scale Standard Deviation 0.71	3.9 score on a scale Standard Deviation 0.76
Knowledge (Young Adult Survivors) Time 2	4.1 score on a scale Standard Deviation 0.67	4.13 score on a scale Standard Deviation 0.68

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

The Skills/Self-Efficacy sub-scale from the Transition Readiness Inventory (TRI) measures self-management skills and self-efficacy for survivorship care using a 5-point scale, with higher scores indicating greater skills/efficacy. A mean score will be calculated (range 1-5).

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Self-Management Skills/Self-Efficacy (Young Adult Survivors) Baseline	3.4 score on a scale Standard Deviation 0.68	3.81 score on a scale Standard Deviation 0.71
Self-Management Skills/Self-Efficacy (Young Adult Survivors) Time 2	3.72 score on a scale Standard Deviation 0.78	3.92 score on a scale Standard Deviation 0.66
Self-Management Skills/Self-Efficacy (Young Adult Survivors) Time 3	3.84 score on a scale Standard Deviation 0.76	4.00 score on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

The Goals subscale from the Transition Readiness Inventory (TRI) measures self-management goals for survivorship care using a 5-point scale, with higher scores indicating greater goals. A mean score will be calculated (range 1-5).

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Self-Management Goals (Young Adult Survivors) Baseline	3.44 score on a scale Standard Deviation 0.91	3.99 score on a scale Standard Deviation 1
Self-Management Goals (Young Adult Survivors) Time 2	4.10 score on a scale Standard Deviation 0.71	4.30 score on a scale Standard Deviation 0.72
Self-Management Goals (Young Adult Survivors) Time 3	4.06 score on a scale Standard Deviation 0.67	4.30 score on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

The Beliefs/Expectations sub-scale from the Transition Readiness Inventory (TRI) measures self-management beliefs for survivorship care using a 5-point scale, with higher scores indicating more positive beliefs. A mean score will be calculated (range 1-5).

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Self-Management Beliefs (Young Adult Survivors) Baseline	3.59 score on a scale Standard Deviation 0.58	3.95 score on a scale Standard Deviation 0.64
Self-Management Beliefs (Young Adult Survivors) Time 2	4.14 score on a scale Standard Deviation 0.45	4.06 score on a scale Standard Deviation 0.66
Self-Management Beliefs (Young Adult Survivors) Time 3	4.21 score on a scale Standard Deviation 0.55	4.13 score on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

This single item measures confidence in communicating with a physician about health concerns using a 10-point scale, with higher scores indicating greater confidence. Range is from 1-10.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Self-efficacy for Communicating With Physician (Young Adult Survivors): Scale Baseline	7.89 score on a scale Standard Deviation 1.76	8.28 score on a scale Standard Deviation 2.16
Self-efficacy for Communicating With Physician (Young Adult Survivors): Scale Time 2	8.74 score on a scale Standard Deviation 1.2	8.82 score on a scale Standard Deviation 1.77
Self-efficacy for Communicating With Physician (Young Adult Survivors): Scale Time 3	8.56 score on a scale Standard Deviation 1.35	8.92 score on a scale Standard Deviation 1.88
Self-efficacy for Communicating With Physician (Young Adult Survivors): Scale Time 4	8.67 score on a scale Standard Deviation 1.19	9.0 score on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

This scale measures confidence in communicating with family about healthcare concerns using a 5-point scale, with higher scores indicating greater confidence. A mean score is calculated (range from 1-5).

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Self-efficacy for Communicating With Family About Healthcare (Young Adult Survivors): Scale Baseline	3.49 score on a scale Standard Deviation 1.04	3.96 score on a scale Standard Deviation 1.03
Self-efficacy for Communicating With Family About Healthcare (Young Adult Survivors): Scale Time 2	4.08 score on a scale Standard Deviation 1.03	4.09 score on a scale Standard Deviation 1.15
Self-efficacy for Communicating With Family About Healthcare (Young Adult Survivors): Scale Time 3	3.91 score on a scale Standard Deviation 1.23	4.36 score on a scale Standard Deviation 1.03
Self-efficacy for Communicating With Family About Healthcare (Young Adult Survivors): Scale Time 4	4.29 score on a scale Standard Deviation 0.89	4.19 score on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

This scale consists of three items measuring confidence in managing late effects using a 5-point scale, with higher scores indicating higher confidence. A mean score is calculated (range 1-5).

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Self-efficacy for Managing Late Effects (Young Adult Survivors): Scale Baseline	2.39 score on a scale Standard Deviation 1	3.05 score on a scale Standard Deviation 1.35
Self-efficacy for Managing Late Effects (Young Adult Survivors): Scale Time 2	3.43 score on a scale Standard Deviation 1.12	3.63 score on a scale Standard Deviation 1.18
Self-efficacy for Managing Late Effects (Young Adult Survivors): Scale Time 3	3.67 score on a scale Standard Deviation 0.97	3.65 score on a scale Standard Deviation 1.14
Self-efficacy for Managing Late Effects (Young Adult Survivors): Scale Time 4	3.7 score on a scale Standard Deviation 0.87	3.54 score on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

This scale consists of three items measuring confidence in survivorship care planning using a 5-point scale, with higher scores indicating higher confidence. A mean score is calculated (range 1-5).

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Self-efficacy for Survivorship Care Planning (Young Adult Survivors): Scale Time 2	3.89 score on a scale Standard Deviation 0.89	3.65 score on a scale Standard Deviation 1.28
Self-efficacy for Survivorship Care Planning (Young Adult Survivors): Scale Time 3	3.92 score on a scale Standard Deviation 1.15	3.96 score on a scale Standard Deviation 1.33
Self-efficacy for Survivorship Care Planning (Young Adult Survivors): Scale Baseline	2.83 score on a scale Standard Deviation 1.21	3.25 score on a scale Standard Deviation 1.53
Self-efficacy for Survivorship Care Planning (Young Adult Survivors): Scale Time 4	4.1 score on a scale Standard Deviation 0.84	3.96 score on a scale Standard Deviation 1.18

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

This scale consists of seven items measuring confidence in managing health insurance using a 5-point scale, with higher scores indicating higher confidence. A mean score is calculated (range 1-5).

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Health Insurance Self-efficacy (Young Adult Survivors): Scale Baseline	2.2 score on a scale Standard Deviation 0.88	2.8 score on a scale Standard Deviation 1.22
Health Insurance Self-efficacy (Young Adult Survivors): Scale Time 2	3.06 score on a scale Standard Deviation 1.25	3.01 score on a scale Standard Deviation 1.18
Health Insurance Self-efficacy (Young Adult Survivors): Scale Time 3	3.45 score on a scale Standard Deviation 1.19	3.55 score on a scale Standard Deviation 1.13
Health Insurance Self-efficacy (Young Adult Survivors): Scale Time 4	3.36 score on a scale Standard Deviation 0.84	3.43 score on a scale Standard Deviation 1.17

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

This scale consists of four items measuring attitudes toward survivorship care using a 5-point scale, with higher scores indicating more positive attitudes. A mean score is calculated (range 1-5).

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Survivorship Care Attitudes (Young Adult Survivors) Baseline	4.07 score on a scale Standard Deviation 0.62	3.99 score on a scale Standard Deviation 0.76
Survivorship Care Attitudes (Young Adult Survivors) Time 2	4.35 score on a scale Standard Deviation 0.66	4.03 score on a scale Standard Deviation 0.93
Survivorship Care Attitudes (Young Adult Survivors) Time 3	4.43 score on a scale Standard Deviation 0.57	4.25 score on a scale Standard Deviation 0.73
Survivorship Care Attitudes (Young Adult Survivors) Time 4	4.54 score on a scale Standard Deviation 0.41	4.2 score on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline)

The Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Emotions-Short Form is an 8-item measure of confidence in managing emotions. A mean score will be calculated (range 1-5). Higher scores indicate higher confidence in managing emotions.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Self-efficacy for Managing Emotions (Young Adult Survivors): Scale Baseline	3.39 score on a scale Standard Deviation 0.9	3.73 score on a scale Standard Deviation 0.87
Self-efficacy for Managing Emotions (Young Adult Survivors): Scale Time 2	3.85 score on a scale Standard Deviation 0.94	3.73 score on a scale Standard Deviation 0.88
Self-efficacy for Managing Emotions (Young Adult Survivors): Scale Time 3	3.97 score on a scale Standard Deviation 0.82	3.86 score on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support-Short Form is a 4-item measure of perceived emotional support. A mean score will be calculated (range 1-5), with higher scores indicative of having better perceived emotional support.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Emotional Support (Young Adult Survivors) Time 2	4.36 score on a scale Standard Deviation 1.04	4.5 score on a scale Standard Deviation 0.76
Emotional Support (Young Adult Survivors) Time 3	4.3 score on a scale Standard Deviation 1.09	4.5 score on a scale Standard Deviation 0.68
Emotional Support (Young Adult Survivors) Baseline	4.18 score on a scale Standard Deviation 0.98	4.47 score on a scale Standard Deviation 0.77
Emotional Support (Young Adult Survivors) Time 4	4.42 score on a scale Standard Deviation 0.75	4.57 score on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

The Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support-Short Form is a 4-item measure of perceived availability of helpful information or advice. A mean score will be calculated (range 1-5), with higher scores indicating higher perceived informational support.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Informational Support (Young Adult Survivors) Time 4	4.31 score on a scale Standard Deviation 0.71	4.29 score on a scale Standard Deviation 0.87
Informational Support (Young Adult Survivors) Baseline	3.99 score on a scale Standard Deviation 0.94	4.35 score on a scale Standard Deviation 0.68
Informational Support (Young Adult Survivors) Time 2	4.41 score on a scale Standard Deviation 0.97	4.4 score on a scale Standard Deviation 0.74
Informational Support (Young Adult Survivors) Time 3	4.23 score on a scale Standard Deviation 1.05	4.43 score on a scale Standard Deviation 0.71

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).

Population: Mammogram measure was only administered to females so the sample size for those analyses represent the number of females in each arm.

As an exploratory outcome, participants will report on receipt of the following healthcare (if applicable): Survivorship Care Plan, annual survivorship visit, echocardiogram within last 5 years, mammogram ever (females only), skin cancer screening ever, primary care visit in last 2 years, dental visit in the last year, annual flu vaccine up-to-date, and human papillomavirus (HPV) vaccine ever. Each item will be treated individually. The number of survivors reporting receipt of each healthcare service will be counted. "Yes" indicates receipt within time frame indicated for the outcome; "No" indicates either not received or not due per self-report.

Outcome measures

Measure	Randomized Control Trial Participants-Young Adult Survivors n=25 Participants Participants for the randomized trial (i.e., Young Adult survivors) were recruited using the New Jersey State Cancer Registry (NJSCR) and the local Long-Term Information Treatment Evaluation (LITE) program.	Usual Care n=25 Participants Participants are not receiving the tested intervention. They continue to receive standard or routine psycho-social or transition care available to them as part of the normal practice.
Healthcare Utilization (Young Adult Survivors) Survivorship Care Plan-Baseline : yes	9 Participants	10 Participants
Healthcare Utilization (Young Adult Survivors) Survivorship Care Plan-Time 3 : yes	18 Participants	15 Participants
Healthcare Utilization (Young Adult Survivors) Survivorship Care Plan-Time 4 : yes	18 Participants	11 Participants
Healthcare Utilization (Young Adult Survivors) Annual survivorship visit-Baseline: yes	20 Participants	16 Participants
Healthcare Utilization (Young Adult Survivors) Annual survivorship visit-Time 3: yes	6 Participants	1 Participants
Healthcare Utilization (Young Adult Survivors) Annual survivorship visit-Time 4: yes	15 Participants	9 Participants
Healthcare Utilization (Young Adult Survivors) Echocardiogram-Baseline: yes	19 Participants	15 Participants
Healthcare Utilization (Young Adult Survivors) Echocardiogram-Time 3: yes	19 Participants	16 Participants
Healthcare Utilization (Young Adult Survivors) Echocardiogram-Time 4: yes	18 Participants	13 Participants
Healthcare Utilization (Young Adult Survivors) Mammogram-Baseline: yes	1 Participants	1 Participants
Healthcare Utilization (Young Adult Survivors) Mammogram-Time 3: yes	1 Participants	1 Participants
Healthcare Utilization (Young Adult Survivors) Mammogram-Time 4: yes	1 Participants	0 Participants
Healthcare Utilization (Young Adult Survivors) Skin cancer screening-Baseline: yes	8 Participants	5 Participants
Healthcare Utilization (Young Adult Survivors) Skin cancer screening-Time 3: yes	6 Participants	7 Participants
Healthcare Utilization (Young Adult Survivors) Skin cancer screening-Time 4: yes	8 Participants	7 Participants
Healthcare Utilization (Young Adult Survivors) Primary care visit-Baseline: yes	21 Participants	24 Participants
Healthcare Utilization (Young Adult Survivors) Primary care visit-Time 3: yes	16 Participants	22 Participants
Healthcare Utilization (Young Adult Survivors) Primary care visit-Time 4: yes	19 Participants	21 Participants
Healthcare Utilization (Young Adult Survivors) Dental visit-Baseline: yes	20 Participants	21 Participants
Healthcare Utilization (Young Adult Survivors) Dental visit-Time 3: yes	20 Participants	17 Participants
Healthcare Utilization (Young Adult Survivors) Dental visit-Time 4: yes	15 Participants	13 Participants
Healthcare Utilization (Young Adult Survivors) Annual flu vaccine-Baseline	14 Participants	12 Participants
Healthcare Utilization (Young Adult Survivors) Annual flu vaccine-Time 3	18 Participants	17 Participants
Healthcare Utilization (Young Adult Survivors) Annual flu vaccine-Time 4	15 Participants	16 Participants
Healthcare Utilization (Young Adult Survivors) Human papillomavirus (HPV) vaccine-Baseline: yes	19 Participants	16 Participants
Healthcare Utilization (Young Adult Survivors) Human papillomavirus (HPV) vaccine-Time 3: yes	19 Participants	16 Participants
Healthcare Utilization (Young Adult Survivors) Human papillomavirus (HPV) vaccine-Time4: yes	20 Participants	17 Participants

Adverse Events

Mentors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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. Katie Devine

Rutgers Cancer Institute of NJ

Phone: 7322357549

Email: katie.devine@rutgers.edu

Results disclosure agreements

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