Genetic Disorder, Von Hippel-Lindau Disease
Conditions
Keywords
Von-Hippel-Lindau Disease, VHL, Genetic Disorder
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.
Interventions
BEHAVIORAL3RP-VHL
An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals with VHL.
Sponsors
Massachusetts General Hospital
The Rappaport Foundation
The Claflin Distinguished Scholar Awards
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3RP-VHL Feasibility: Percent of Identified Eligibles Who Enroll | Post-treatment completion (treatment is approximately 2 months) | Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). |
| 3RP-VHL Feasibility: Proportion of Participants Completing the 3RP-VHL Program | Post-treatment completion (treatment is approximately 2 months) | Among those who initiated the program, this is the proportion of patients who completed the program (defined as completing 6 out of 8 sessions). Participants who complete at least 75% of the treatment sessions (6 out of 8 sessions) will be identified as treatment completers. |
| 3RP-VHL Acceptability: Five Questions | Post-treatment completion (treatment is approximately 2 months) | Acceptability will be assessed with five questions rated on a 4-point Likert scale (1=not at all to 4=very). More specifically, acceptability will be defined as ≥75% of responses rated at least 3/4 on enjoyableness, convenience, helpfulness, future use, and satisfaction. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGiselle Perez, PhD
Massachusetts General Hospital
Outcome results
None listed