Actively Recruiting
Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Led by University of Virginia · Updated on 2024-12-16
30
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
A
American Cancer Society, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willingness to comply with study procedures and availability for the study duration
- Male or female aged 18 years or older
- Good surgical candidate as determined by treating surgeon
- Histologically confirmed muscle invasive urothelial carcinoma, high-risk non-muscle invasive bladder cancer, non-muscle invasive bladder cancer refractory to BCG, cisplatin ineligible muscle invasive bladder cancer receiving upfront cystectomy, or urothelial carcinoma with variant histology
- Adequate organ function as defined by protocol
- ECOG performance status 2 or less
- Medical clearance to complete cardiopulmonary exercise testing
- Willing to use personal or study provided devices for exercise monitoring
- Fluent in English or Spanish for questionnaire completion
- No known contraindications to high intensity exercise
You will not qualify if you...
- Contraindications to aerobic exercise
- Currently participating in an aerobic exercise program
- New onset chest pain or shortness of breath with exertion
- Histologically documented micropapillary or sarcomatoid bladder cancer
- Presence of distant metastatic carcinoma
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
C
Christine Ibilibor
CONTACT
F
Francesca Whitefield
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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