NCT05790850Recruiting
Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 16 Mar 2023
- Start date
- 30 Mar 2023
- Primary completion date
- Oct 2025
- Lead sponsor
- University of Virginia
- Diseases
- Bladder cancer
- NCT number
- NCT05790850
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 30 Mar 2023 to the primary completion date, Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Histologically documented micropapillary or sarcomatoid bladder cancer
Other
- Contraindications to participating in aerobic exercise
- Currently participating in an aerobic exercise program
- New onset chest pain nor dyspnea with exertion
- Distant metastatic carcinoma
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.