Tests exercise and mindfulness before surgery for bladder cancer
Tests home exercise and mindfulness before bladder removal in adults with bladder cancer.
Key facts
- Who runs it
- University of Virginia
- Where
- Charlottesville, United StatesSee the site
- Trial code
- Registry title
- Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 30 Mar 2023
- Planned end
- Jun 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Pre-operative physical exercise
- Pre-operative mindfulness meditation practice
- Record updated
- 16 December 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with bladder cancer who are planned for bladder removal surgery (radical cystectomy). They would try a home exercise and mindfulness program before surgery.
- Age
- 18 to 90 years
- Sex
- Men and women
- Disease stage
- Muscle-invasive urothelial bladder cancer, high-risk non-muscle-invasive bladder cancer, non-muscle-invasive bladder cancer that did not respond to BCG, muscle-invasive bladder cancer where cisplatin cannot be used and surgery comes first, or bladder cancer with variant histology.
Main reasons for not taking part
- Contraindications to aerobic exercise
- Already in an aerobic exercise program
- New chest pain or breathlessness with exertion
- Micropapillary or sarcomatoid bladder cancer
- Distant metastatic cancer
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Histologically documented micropapillary or sarcomatoid bladder cancer
- Contraindications to participating in aerobic exercise
- Currently participating in an aerobic exercise program
- New onset chest pain nor dyspnea with exertion
- Distant metastatic carcinoma
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Where in United States
- University of VirginiaCharlottesville, United StatesContact: Christine IbiliborTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ControlNo study treatment, for comparison
Usual preoperative care prior to radical cystectomy
- InterventionTreatment being tested
Preoperative pre-habilitation
Treatment: Pre-operative physical exercise and Pre-operative mindfulness meditation practice
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
- Plain-language title
- Tests exercise and mindfulness before surgery for bladder cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05790850, who can take part
- Record updated
- 16 December 2024