Clinical trial NCT03768336: A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors
Official title: A Stress Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Cancer
Behavioral Intervention
Adolescent
Young Adult
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-12-07
Enrollment: 72
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll
timeFrame: Post-treatment completion (treatment is approximately 8 weeks)
measure: 3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program
timeFrame: Post-treatment completion (treatment is approximately 8 weeks)
measure: 3RP-AYA Acceptability: Five Questions
timeFrame: Post-treatment completion (treatment is approximately 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Giselle K. Perez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.