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

NCT ID: NCT03768336

Last Updated: 2025-06-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2025-08-01

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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Waitlist control

Intervention Type 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.

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

Group Type EXPERIMENTAL

3RP-AYA

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Giselle K. Perez Lougee

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giselle K. Perez, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35080500 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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18-428

Identifier Type: -

Identifier Source: org_study_id

1K07CA211955-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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