Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Part of paid clinical trials in Charlottesville, Virginia.
- Sponsor
- University of Virginia
- Study ID
- NCT05790850
- Status
- Recruiting
Conditions
- Bladder Cancer
- Muscle-Invasive Bladder Carcinoma
- Non-muscle-invasive Bladder Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Pre-operative physical exercise — BEHAVIORALVirtual instructor-guided twice weekly cycling-based high-intensity aerobic exercise program for a total of 30 days. Participants will use a study provided recumbent exercise bike and wristband fitness tracker to exercise and log the number of days they exercise with an instructor and self-directed cycling.
- Pre-operative mindfulness meditation practice — BEHAVIORALDaily self-directed mindfulness practice involving a guided imagery meditation for a total of 30 days. Participants will use a study provided guided-imagery meditation audio file loaded to a study provided wristband fitness tracker. Participants will log the number of days they listen to the audio file or participate in self-directed solitary psychological support.
Study Details
The PRIMER (Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy) trial is a pilot designed to estimate the feasibility of integrating a home-based pre-operative exercise and mindfulness program (pre-habilitation program) for patients scheduled to undergo radical cystectomy for bladder cancer in an attempt to improve both physical and psychological conditioning pre-operatively.
Key Dates
- Start date
- Mar 30, 2023
- Status verified
- Dec 2024
- Primary completion
- Oct 31, 2025
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- No Intervention: ControlUsual preoperative care prior to radical cystectomy
- Experimental: InterventionPreoperative pre-habilitation
Primary Outcome Measure
Number of patient-reported days devoted to solitary psychological support [ Time Frame: 30 days ]
Central Contacts
- Christine Ibilibor4349240871
- Francesca Whitefield4349240871
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | Christine Ibilibor Ashley Byrne Christine Ibilibor, MD |
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