Trial Outcomes & Findings for A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors (NCT NCT03768336)
NCT ID: NCT03768336
Last Updated: 2025-06-04
Results Overview
Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). Qualitative information from experts and participants will be used to inform feasibility.
ACTIVE_NOT_RECRUITING
NA
72 participants
Post-treatment completion (treatment is approximately 8 weeks)
2025-06-04
Participant Flow
As per our approved protocol, only individuals who signed consent and completed the baseline assessment were considered to be enrolled. Hence, 72 people met this criteria.
Participant milestones
| Measure |
3RP Group Sessions
The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions immediately after enrollment.
|
Waitlist Control
The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions 2-months after enrollment.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
|
Overall Study
Baseline Completion
|
35
|
37
|
|
Overall Study
Remained Eligible
|
33
|
37
|
|
Overall Study
Program Initiation
|
29
|
35
|
|
Overall Study
Follow up Survey #1
|
29
|
35
|
|
Overall Study
Follow up Survey #2
|
29
|
34
|
|
Overall Study
COMPLETED
|
29
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
3RP Group Sessions
The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions immediately after enrollment.
|
Waitlist Control
The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions 2-months after enrollment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Became Ineligible
|
2
|
0
|
|
Overall Study
Missed final survey (3-month follow-up)
|
1
|
0
|
|
Overall Study
Missed final survey (post-treatment
|
0
|
1
|
Baseline Characteristics
A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors
Baseline characteristics by cohort
| Measure |
Enrolled Patients
n=72 Participants
All participants who consented and completed the baseline survey
|
|---|---|
|
Age, Continuous
|
23.76 years
STANDARD_DEVIATION 3.26 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
18 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
53 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Prefer not to describe
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Mixed Race
|
5 Participants
n=5 Participants
|
|
Months since treatment completion
|
18.82 months
STANDARD_DEVIATION 16.06 • n=5 Participants
|
PRIMARY outcome
Timeframe: Post-treatment completion (treatment is approximately 8 weeks)Population: This consists of the total number of individuals who were eligible, were approached and informed about the study, and were offered the opportunity to participate.
Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). Qualitative information from experts and participants will be used to inform feasibility.
Outcome measures
| Measure |
Total Individuals Approached
n=93 Participants
This consists of eligible individuals who were approached and informed about the study (thus had the opportunity to participate)
|
|---|---|
|
3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll
Enrolled
|
72 Participants
|
|
3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll
Active refusal
|
9 Participants
|
|
3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll
Passive refusal (made contact but never heard back)
|
10 Participants
|
|
3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll
Interested but unable to make groups
|
2 Participants
|
PRIMARY outcome
Timeframe: Post-treatment completion (treatment is approximately 8 weeks)Population: Total number of patients who initiated the program.
Among those who initiated the program, this is the proportion of patients who completed the program (defined as completing 6 out of 8 sessions). Qualitative information from experts and participants will be used to inform feasibility.
Outcome measures
| Measure |
Total Individuals Approached
n=64 Participants
This consists of eligible individuals who were approached and informed about the study (thus had the opportunity to participate)
|
|---|---|
|
3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program
Completed 6 out of 8 3RP-AYA sessions.
|
55 Participants
|
|
3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program
Completed less than 6 3RP-AYA
|
9 Participants
|
PRIMARY outcome
Timeframe: Post-treatment completion (treatment is approximately 8 weeks)Population: These were inclusive of all responses to the acceptability items.
Acceptability will be assessed with five questions rated on a 4-point Likert scale (1=not at all to 4=very). Items will prompt participants to rate the extent to which they found the program to be enjoyable, helpful, applicable, convenient, and satisfaction. Qualitative information from experts and patients will also inform acceptability.
Outcome measures
| Measure |
Total Individuals Approached
n=60 Participants
This consists of eligible individuals who were approached and informed about the study (thus had the opportunity to participate)
|
|---|---|
|
3RP-AYA Acceptability: Five Questions
How enjoyable was the program
|
3.62 units on a scale
Standard Deviation .69
|
|
3RP-AYA Acceptability: Five Questions
How helpful was the program?
|
3.45 units on a scale
Standard Deviation .75
|
|
3RP-AYA Acceptability: Five Questions
How relevant was the program?
|
3.60 units on a scale
Standard Deviation .74
|
|
3RP-AYA Acceptability: Five Questions
How convenient was the program
|
3.67 units on a scale
Standard Deviation .71
|
|
3RP-AYA Acceptability: Five Questions
How satisfied are you with the content?
|
3.6 units on a scale
Standard Deviation .62
|
Adverse Events
Waitlist Control
3RP Group Sessions
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Giselle K. Perez
Massachusetts General Hospital/Harvard Medical Schoool
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place