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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03768336
• Other study ID #: 18-428
• Secondary ID: 1K07CA211955-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: August 1, 2024

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: August 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 29 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)