NCT05790850 Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
| NCT ID | NCT05790850 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Virginia |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-03-30 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-03-30 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥18 years of age * Good surgical candidate determined by treating surgeon * Histologically documented muscle invasive urothelial carcinoma of the bladder, high-risk non-muscle invasive bladder cancer, non-muscle invasive bladder cancer refractory to BCG, cisplatin ineligible muscle invasive bladder cancer receiving upfront cystectomy, urothelial carcinoma of the bladder with variant histology * Adequate Organ Function per protocol definition * ECOG performance status ≤2 * Received medical clearance to complete cardiopulmonary exercise testing * Willing to use the personal or study provided devices for monitoring and performing the exercise routines. * Fluent in English or Spanish for the EORTC QLQ questionnaire * No known contraindications to high intensity exercise Exclusion Criteria: * Contraindications to participating in aerobic exercise * Currently participating in an aerobic exercise program * New onset chest pain nor dyspnea with exertion * Histologically documented micropapillary or sarcomatoid bladder cancer * Distant metastatic carcinoma
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05790850 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05790850 currently recruiting?
Yes, NCT05790850 is actively recruiting participants. Contact the research team at ci5d@virginia.edu for enrollment information.
Where is the NCT05790850 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT05790850 clinical trial?
NCT05790850 is sponsored by University of Virginia. The trial plans to enroll 30 participants.
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