Mindfulness and exercise program for bladder cancer surgery patients
Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
This study is testing a home program that combines exercise and mindfulness to help bladder cancer patients feel better and prepare for their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05790850 on ClinicalTrials.gov |
What this trial studies
The PRIMER trial aims to evaluate the feasibility of a home-based pre-operative program that combines physical exercise and mindfulness meditation for patients scheduled to undergo radical cystectomy due to bladder cancer. This pilot study focuses on improving both the physical and psychological conditioning of patients before surgery. Participants will engage in structured exercise routines and mindfulness practices to enhance their overall well-being and readiness for the surgical procedure.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific types of bladder cancer who are deemed good surgical candidates.
Not a fit: Patients with contraindications to high-intensity exercise or those not fluent in English or Spanish may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could lead to improved recovery outcomes and quality of life for patients undergoing radical cystectomy.
How similar studies have performed: Other studies have shown promising results with pre-habilitation approaches combining exercise and mindfulness, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Christine Ibilibor
- Email: ci5d@virginia.edu
- Phone: 4349240871
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.