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 adults 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.
Additional locations may be listed on ClinicalTrials.gov for NCT03768336.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
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 14 and 29 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 PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorGiselle Perez