This clinical trial tests how well a relaxation response resiliency program (3RP) works in promoting stress management and resilience in patients with Von Hippel-Lindau disease (VHL). VHL is rare, inherited disorder that causes tumors and cysts to grow in certain parts of the body, including the brain, spinal cord, eyes, inner ear, adrenal glands, pancreas, kidney, and reproductive tract. The tumors are usually benign (not cancer), but some may be malignant (cancer). VHL patients experience a range of unique physical health challenges and have been identified as having unmet psychosocial needs (including symptoms such as chronic fatigue, anxiety, depression, high risk of recurrence, and fear of recurrence) persisting throughout the lifetime. The goal of the 3RP-VHL is to help reduce stress and promote stress-management among individuals diagnosed with VHL. Researchers want to learn if adapting a mind-body group program could help adults manage the challenges of living with a VHL diagnosis to reduce stress and improve the well-being and quality of life of patients living with VHL.
Additional locations may be listed on ClinicalTrials.gov for NCT05737602.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Giselle Perez
Phone: 617-724-0287
PRIMARY OBJECTIVES:
I. Conduct qualitative interviews with approximately 10 adults with VHL and 10 caregivers (for this study, defined as close family members involved in their care. This includes spouses, children aged 18+, grandparents, etc) to inform the adaptation of a resiliency group intervention aimed at reducing stress and increasing coping. (Phase I)
II. To examine the feasibility and acceptability of a group-based, stress-management and resiliency intervention via videoconferencing technology for VHL patients. (Phase II)
EXPLORATORY OBJECTIVE:
I. To examine the preliminary effects of the intervention on psychosocial measures of distress (anxiety, depression, worry, intolerance of uncertainty, coping, self-efficacy, resilience, quality of life, fear of progression, loneliness, reproductive concerns, and self-compassion). (Phase II)
OUTLINE:
PHASE I: Participants complete surveys and participate in an interview to elicit feedback about 3RP for program refinement on study.
PHASE II: Patients participate in virtual 3RP-VHL group sessions weekly over 90 minutes each for 9 weeks and receive a patient manual on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorGiselle Perez