A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors

Study Overview
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Brief Summary
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This research study aims to explore the feasibility and acceptability of an adapted resiliency group program, called the Relaxation Response Resiliency Program (3RP-AYA), to reduce stress and promote stress-management among adolescents and young adults who have completed treatment for cancer.

Detailed Description
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The Relaxation Response Resiliency Program, or 3RP, was developed by researchers at the MGH Benson-Henry Institute for Mind Body Medicine. The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being. The 3RP has not yet been carried out with adolescent or young adult individuals who have recently completed treatment for cancer. As such, the investigators have adapted the original 3RP to target the specific needs of adolescent and young adult patients who are transitioning off active treatment. The investigators are conducting this study to see if the adapted program, the 3RP-AYA, is effective at reducing stress and stress-related symptoms for people of at least age 16 who have completed treatment for cancer within the past five years.

Official Title
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A Stress Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors

Conditions
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Cancer

Intervention / Treatment
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* Other: Waitlist control
* Other: 3RP-AYA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with any cancer between ages 14 and 29 Completed cancer treatment within the past 5 years At least 16 years of age at time of enrollment Exclusion Criteria: Unwilling or unable to participate in the study Unable to speak or read English Is medically or otherwise unable to participate (as determined by a physician or study PI) Unwilling or unable to participate in study sessions delivered via the Partners Telehealth videoconferencing software Participation in a focus group during Phase 1 (DF/HCC 17-315)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Waitlist Control<br>The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions Mini relaxation practice Weekly goal check-ins RR-practice | Other: Waitlist control<br>* The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being. Waitlist control receives the adapted 3RP program (3RP-AYA) approximately 2 months after study enrollment.<br>|
| Experimental: 3RP Group Sessions<br>The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions Mini relaxation practice Weekly goal check-ins RR-practice | Other: 3RP-AYA<br>* The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll | 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. | Post-treatment completion (treatment is approximately 8 weeks) | 
| 3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA 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. | Post-treatment completion (treatment is approximately 8 weeks) | 
| 3RP-AYA Acceptability: Five Questions | 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. | Post-treatment completion (treatment is approximately 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Behavioral Intervention, Adolescent, Young Adult