Genetic Disorder Clinical Trial
Official title:
Promoting Stress Management and Resilience Among Individuals With Von Hippel- Lindau Disease
NCT number | NCT05737602 |
Other study ID # | 22-612 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2024 |
Est. completion date | July 1, 2025 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 1, 2025 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | The Claflin Distinguished Scholar Awards, The Rappaport Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3RP-VHL Feasibility: Percent of Identified Eligibles Who Enroll | Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). | Post-treatment completion (treatment is approximately 2 months) | |
Primary | 3RP-VHL Feasibility: Proportion of Participants Completing the 3RP-VHL Program | 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. | Post-treatment completion (treatment is approximately 2 months) | |
Primary | 3RP-VHL Acceptability: Five Questions | 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. | Post-treatment completion (treatment is approximately 2 months) |
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