3RP-AYA Intervention in Reducing Stress and Promoting Stress Management in Adolescent and Young Adult Cancer Survivors

Status: Active

Description

This trial studies the feasibility and acceptability of Relaxation Response Resiliency Program for adolescent and young adult (3RP-AYA) intervention in reducing stress and promoting stress management in adolescent and young adult who have completed treatment for cancer within the past five years. 3RP-AYA intervention uses a variety of mind-body approaches, such as imagery, relaxation, and yoga that may buffer stress and promote psychological resiliency and physical well-being in adolescent and young adult cancer survivors.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with any cancer between ages 15 and 27
  • Completed cancer treatment within the past 5 years

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 principal investigator [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) or the sister-protocol (DF/HCC 17-063)

Locations & Contacts

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Contact: Lisa Brazzamano Kenney
Phone: 617-632-2292
Email: lbkenney@partners.org
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Giselle Perez
Phone: 617-724-0765
Email: Gperez@mgh.harvard.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To examine, in a pilot randomized controlled trial (RCT) (total n=72, goal of having approximately n=60 completers), the feasibility and acceptability of an 8-session stress-management and resiliency group program (3RP-AYA) delivered via videoconference technology for survivors of AYA cancer between the ages of 16-29 at study enrollment, but who were diagnosed between ages 15 and 27 and who are within 5 years of treatment completion.

EXPLORATORY OBJECTIVES:

I. Examine the preliminary effects of the 3RP-AYA on stress and stress management among AYAs.

II. Examine the preliminary effects of the 3RP-AYA on psychosocial measures of mindfulness, depressed mood, anxiety and stress collected at three timepoints: T0 (baseline), T1 (immediate start resiliency intervention group [IG]: posttreatment, waitlist control group [WG]: baseline), T2 (IG: 3 month follow-up, WG: posttreatment).

III. Explore the feasibility and acceptability of collecting hair samples to examine intervention-related changes in cortisol, a stress biomarker.

IV. Examine AYA reasons for deciding not to participate in this behavioral trial.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive 3RP-AYA intervention consisting of a group session once weekly over 90 minutes each for 8 weeks.

GROUP II: Patients receive 3RP-AYA intervention consisting of a group session once weekly over 90 minutes each for 8 weeks after 3 months.

After completion of study program, patients are followed up at 3 months.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Giselle Perez

Trial IDs

Primary ID 18-428
Secondary IDs NCI-2018-03786
Clinicaltrials.gov ID NCT03768336