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

NCT03768336 | Active Not Recruiting Results

• 2 other identifiers: 18-4281K07CA211955-01A1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Behavioral Intervention; Adolescent; Young Adult

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Waitlist Control

ACTIVE COMPARATOR

* 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

3RP Group Sessions

EXPERIMENTAL

* 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

Interventions

Waitlist control OTHER

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.

Waitlist Control

3RP-AYA OTHER

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.

3RP Group Sessions

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02214, United States

Location

Related Publications (1)

• Mizrach H, Goshe B, Park ER, Recklitis C, Greer JA, Chang Y, Frederick N, Abrams A, Tower MD, Walsh EA, Huang M, Kenney L, Homans A, Miller K, Denninger J, Usmani GN, Peppercorn J, Perez GK. Randomized Waitlist-Control Trial of a Web-Based Stress-Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors: Protocol for the Bounce Back Study. JMIR Res Protoc. 2022 Jan 26;11(1):e34033. doi: 10.2196/34033.

  PMID: 35080500 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Giselle K. Perez
• Organization: Massachusetts General Hospital/Harvard Medical Schoool

gperez@mgh.harvard.edu

617-724-0765

Study Officials

• Giselle K. Perez, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 7, 2018
• Study Start: April 1, 2019
• Primary Completion: March 1, 2023
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 14, 2026
• Results First Posted: December 28, 2022

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)