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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03768336
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 72
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: Waitlist control; Other: 3RP-AYA	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Stress Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Waitlist Control 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; 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.
Experimental: 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 Mini relaxation practice Weekly goal check-ins RR-practice	Other: 3RP-AYA; 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.

Outcome Measures

Primary Outcome Measures

1. 3RP-AYA Feasibility: Percent of identified eligibles who enroll [Post-treatment completion (approximately 8 weeks)]

   Percent of identified eligibles who enroll (i.e., sign consent and complete baseline). Attendance to the sessions will also be considered as a component of feasibility

2. 3RP-AYA Acceptability: five questions [Post-treatment completion (approximately 8 weeks)]

   Acceptability will be assessed with five questions rated on a 5-point Likert scale (1=not at all to 5=very much). Items will prompt participants to rate the extent to which they found the program to be enjoyable, helpful, applicable, convenient, and if they are likely to use strategies in the future.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 29 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02214

Sponsors and Collaborators

• Massachusetts General Hospital
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Giselle K. Perez, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Giselle K. Perez Lougee, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03768336
• Other Study ID Numbers: 18-428; 1K07CA211955-01A1
• First Posted: Dec 7, 2018
• Last Update Posted: Nov 10, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Giselle K. Perez Lougee, Principal Investigator, Massachusetts General Hospital: Cancer; Behavioral Intervention; Adolescent; Young Adult

Study Results

No Results Posted as of Nov 10, 2021