Clinical trial NCT05737602: Promoting Stress Management and Resilience Among Individuals With Von Hippel- Lindau Disease
Official title: Promoting Stress Management and Resilience Among Individuals With Von Hippel- Lindau Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Von Hippel-Lindau Disease
Genetic Disorder
Keywords: Von-Hippel-Lindau Disease
VHL
Genetic Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Rappaport Foundation
name: The Claflin Distinguished Scholar Awards
First posted: 2023-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Relaxation Response Resiliency Program (3RP) has shown efficacy in improving coping and resilience across diverse populations; however, little is known about how it helps individuals manage the challenges of living with a chronic illness. This study proposes to pilot test an adapted version of the 3RP among patients living with VHL.

Detailed description: The 3RP has not been carried out with VHL patients. As such, the investigators are looking to see if an adapted program, tailored to the needs of patients with VHL, is feasible, acceptable, and helpful in improving coping among individuals living with VHL.

This study is a two phase trial. Phase I is descriptive. It is comprised of conducting interviews with patients and caregivers to understand the challenges of living with VHL and patient's programatic needs. This information will be used to tailor the program for patients living with VHL. Phase II is a single-arm feasibility trial that will examine if the adapted program is feasible, acceptable, and helps promote stress management among VHL patients. To these means, we will test the adapted 3RP (3RP-VHL) in up to 40 patients living with VHL. Participants will complete surveys at baseline and post 3RP-VHL program completion. This record will reflect the trial component (Phase II) only, as feasibility and acceptability outcomes will be collected for this phase.

Eligibility criteria: Inclusion Criteria:

* Ages 18+
* Confirmed diagnosis of VHL

Exclusion Criteria:

* Is medically, psychiatrically, or otherwise unable to participate (as determined by a physician or study PI).
* Unwilling or unable to participate in study sessions delivered via Partners Telehealth videoconferencing.
* Participated in Phase 1 qualitative interview.

Primary outcomes:
measure: 3RP-VHL Feasibility: Percent of Identified Eligibles Who Enroll
timeFrame: Post-treatment completion (treatment is approximately 2 months)
measure: 3RP-VHL Feasibility: Proportion of Participants Completing the 3RP-VHL Program
timeFrame: Post-treatment completion (treatment is approximately 2 months)
measure: 3RP-VHL Acceptability: Five Questions
timeFrame: Post-treatment completion (treatment is approximately 2 months)
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 Perez, PhD
role: PRINCIPAL_INVESTIGATOR
References: