Trial Outcomes & Findings for PLAN Intervention to Enhance Engagement of Latino Cancer Patients in Advanced Care Planning (NCT NCT04889144)
NCT ID: NCT04889144
Last Updated: 2025-09-09
Results Overview
Will be measured by intervention completion (Benchmark: \>= 70% complete the intervention sessions).
COMPLETED
NA
27 participants
Five weeks post-randomization (for intervention arm only)
2025-09-09
Participant Flow
Please note that a total of n=27 patients enrolled in this study, n=22 completed baseline, and n=20 were randomized. As such, we can only provide baseline characteristics by intervention group for n=20 patients. Additionally, n=11 patients completed follow-up surveys, so all data reporting requiring follow-up data is provided for those n=11 patients.
Participant milestones
| Measure |
Arm I (PLAN Intervention)
Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.
Communication Intervention: Participate in PLAN intervention
Questionnaire Administration: Ancillary studies
|
Arm II (Best Practice)
Patients receive usual care.
Best Practice: Receive usual care
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
For age, n=1 patient in the control condition did not provide a value so only n=8 are reported out of the n=9 who completed the baseline. Similarly, n=19 are reported out of n=20 for the overall column.
Baseline characteristics by cohort
| Measure |
Arm I (PLAN Intervention)
n=11 Participants
Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.
Communication Intervention: Participate in PLAN intervention
Questionnaire Administration: Ancillary studies
|
Arm II (Best Practice)
n=9 Participants
Patients receive usual care.
Best Practice: Receive usual care
Questionnaire Administration: Ancillary studies
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 9.31 • n=11 Participants • For age, n=1 patient in the control condition did not provide a value so only n=8 are reported out of the n=9 who completed the baseline. Similarly, n=19 are reported out of n=20 for the overall column.
|
50.2 years
STANDARD_DEVIATION 12.10 • n=8 Participants • For age, n=1 patient in the control condition did not provide a value so only n=8 are reported out of the n=9 who completed the baseline. Similarly, n=19 are reported out of n=20 for the overall column.
|
51.4 years
STANDARD_DEVIATION 10.29 • n=19 Participants • For age, n=1 patient in the control condition did not provide a value so only n=8 are reported out of the n=9 who completed the baseline. Similarly, n=19 are reported out of n=20 for the overall column.
|
|
Sex/Gender, Customized
Female
|
2 Participants
n=11 Participants
|
5 Participants
n=9 Participants
|
7 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Male
|
8 Participants
n=11 Participants
|
4 Participants
n=9 Participants
|
12 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
20 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=11 Participants
|
8 Participants
n=9 Participants
|
13 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
9 participants
n=9 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Five weeks post-randomization (for intervention arm only)Population: Please note: Only participants assigned to the intervention arm (Arm 1) were assessed for this outcome measure.
Will be measured by intervention completion (Benchmark: \>= 70% complete the intervention sessions).
Outcome measures
| Measure |
Arm I (PLAN Intervention)
n=11 Participants
Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.
Communication Intervention: Participate in PLAN intervention
Questionnaire Administration: Ancillary studies
|
Arm II (Best Practice)
Patients receive usual care.
Best Practice: Receive usual care
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Feasibility (Number/Proportion of Participants Who Completed the Intervention)
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Five weeks post-randomization (for intervention arm only)Population: Please note: Only participants who completed the intervention were assessed for this outcome measure.
Will be measured by a single-item question assessing helpfulness of the intervention (1 = not at all helpful, 5 = very helpful) as well an open-ended question about helpfulness of the intervention ("What was helpful about the intervention?") (Benchmark: \>= 70% rate it as "helpful" or "very helpful"). Data reported as a count number of those who reported "4=helpful" or "5=very helpful" to this question.
Outcome measures
| Measure |
Arm I (PLAN Intervention)
n=5 Participants
Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.
Communication Intervention: Participate in PLAN intervention
Questionnaire Administration: Ancillary studies
|
Arm II (Best Practice)
Patients receive usual care.
Best Practice: Receive usual care
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Acceptability (Helpfulness of the Intervention)
Reported "4=helpful"
|
0 Participants
|
—
|
|
Acceptability (Helpfulness of the Intervention)
Reported "5=very helpful"
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)Population: Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure.
Knowledge subscale of the Advance Care Planning Engagement survey, which is a 49-item scale with high reliability (Cronbach's alpha = .94). Subscale is 6 items with Likert-type answers ranging from 1=not at all to 5=extremely. Responses to these 6 items are summed to create total scores, ranging from 6 (low levels of knowledge) to 30 (high levels of knowledge). Higher scores indicate higher levels of knowledge. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance.
Outcome measures
| Measure |
Arm I (PLAN Intervention)
n=4 Participants
Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.
Communication Intervention: Participate in PLAN intervention
Questionnaire Administration: Ancillary studies
|
Arm II (Best Practice)
n=7 Participants
Patients receive usual care.
Best Practice: Receive usual care
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in Knowledge of Advance Care Planning
|
2.75 score on a scale
Standard Deviation 3.40
|
1.86 score on a scale
Standard Deviation 3.48
|
PRIMARY outcome
Timeframe: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)Population: Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure.
Readiness/motivation subscale of the Advance Care Planning Engagement survey, which is a 49-item scale with high reliability (Cronbach's alpha = .94). Subscale is 10 items with Likert-type answers ranging from 1=not at all to 5=extremely. Scores from these items are summed to created total scores, ranging from 10 (low level of readiness/motivation) to 60 (high level of readiness/motivation). Higher scores indicate higher levels of readiness/motivation. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance.
Outcome measures
| Measure |
Arm I (PLAN Intervention)
n=4 Participants
Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.
Communication Intervention: Participate in PLAN intervention
Questionnaire Administration: Ancillary studies
|
Arm II (Best Practice)
n=7 Participants
Patients receive usual care.
Best Practice: Receive usual care
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in Readiness/Motivation to Engage in Advance Care Planning
|
10.0 score on a scale
Standard Deviation 18.89
|
1.0 score on a scale
Standard Deviation 6.08
|
PRIMARY outcome
Timeframe: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)Population: Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure.
Self-efficacy subscale of the Advance Care Planning Engagement survey, which is a 49-item scale with high reliability (Cronbach's alpha = .94). Subscale is 6 items with Likert-type answers ranging from 1=not at all to 5=extremely. These items are summed to create total scores, ranging from 6 (low levels of self-efficacy) to 30 (high levels of self-efficacy). Higher scores indicated higher levels of self-efficacy. Mean score differences were calculated between baseline and follow-up for each study arm and tested for significance. Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization.
Outcome measures
| Measure |
Arm I (PLAN Intervention)
n=4 Participants
Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.
Communication Intervention: Participate in PLAN intervention
Questionnaire Administration: Ancillary studies
|
Arm II (Best Practice)
n=7 Participants
Patients receive usual care.
Best Practice: Receive usual care
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in Self-efficacy to Engage in Advance Care Planning
|
0.00 score on a scale
Standard Deviation 4.27
|
0.86 score on a scale
Standard Deviation 5.30
|
PRIMARY outcome
Timeframe: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)Population: Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure.
End-of-life care discussions will be measured by asking patients to self-report whether they have discussed any of the following: (1) wishes they have about the care they would like to receive if they were dying and/or (2) advance care directives, with an oncology provider or family member: DNR orders, living wills, durable powers of attorney for health care (yes/no format). Engagement will be measured as a count to the degree to which they engaged in each of these, with no=0 and yes=1. Total score can range from 0 (low or none) to 8 (high or discussed all domains with providers and family). Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization,
Outcome measures
| Measure |
Arm I (PLAN Intervention)
n=4 Participants
Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.
Communication Intervention: Participate in PLAN intervention
Questionnaire Administration: Ancillary studies
|
Arm II (Best Practice)
n=7 Participants
Patients receive usual care.
Best Practice: Receive usual care
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in Engagement in Advance Care Planning (End-of-life Care Discussions)
|
2.50 score on a scale
Standard Deviation 1.73
|
1.29 score on a scale
Standard Deviation 3.20
|
PRIMARY outcome
Timeframe: Baseline, five weeks post-randomization (after randomizing and completing the 3-week intervention if assigned)Population: Due to the small sample size, inferential statistics were not run. Only participants who completed all study activities (e.g., follow-up surveys) were assessed for this outcome measure.
Completion of advance directives will be assessed by examining the medical chart for completed advance directive documents (DNR order, living will, health care proxy/durable power of attorney). Completion will be measured as a count to the degree to which they completed each of these, with no=0 and yes=1. Scores can range from 0 (low or none completed) to 3 (high or all completed). Data reported is the mean change in this outcome from pre-randomization/baseline to post-randomization.
Outcome measures
| Measure |
Arm I (PLAN Intervention)
n=4 Participants
Patients participate in PLAN intervention, consisting of 3 coaching sessions over 45-60 minutes each with a health coach.
Communication Intervention: Participate in PLAN intervention
Questionnaire Administration: Ancillary studies
|
Arm II (Best Practice)
n=7 Participants
Patients receive usual care.
Best Practice: Receive usual care
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in Completion of Advance Directives
|
0.0 score on a scale
Standard Deviation 0.82
|
0.43 score on a scale
Standard Deviation 0.53
|
Adverse Events
Arm I (PLAN Intervention)
Arm II (Best Practice)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Megan Shen, Associate Professor
Fred Hutchinson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place