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
34 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
Researchers are studying a program combining mindfulness and exercise before surgery for patients with bladder cancer who are scheduled to have their bladder removed (radical cystectomy). This pilot trial aims to see if it is feasible to use a home-based pre-operative exercise and mindfulness program to improve patients' physical and psychological health before surgery. The study is led by the University of Virginia and focuses on patients with muscle-invasive or high-risk non-muscle-invasive bladder cancer. Participants are randomly assigned to either usual preoperative care or a prehabilitation program that includes two main parts: a virtual, twice-weekly cycling exercise guided by an instructor using a special exercise bike and wristband tracker, and daily self-directed mindfulness meditation using guided imagery audio on a wristband tracker. Both parts last for 30 days before surgery, with participants logging their exercise and meditation days. During the study, researchers will track how many days participants spend exercising and engaging in solitary psychological support over 30 days. They will also assess post-operative complications within 30 days after surgery and measure quality of life, peak oxygen uptake, mindfulness, and stress levels before and after surgery using questionnaires and exercise testing. Participants must be able to use the study devices and complete the exercise safely. The study period includes pre-operative monitoring and follow-up assessments up to 30 days after surgery.
CONDITIONS
Brief 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 and dated informed consent form
- Willingness to comply with all study procedures and availability for study duration
- Male or female aged 18 years or older
- Good surgical candidate as determined by treating surgeon
- Histologically documented muscle invasive urothelial carcinoma of the bladder or high-risk non-muscle invasive bladder cancer
- Adequate organ function per protocol
- ECOG performance status of 2 or less
- Medical clearance to complete cardiopulmonary exercise testing
- Willingness to use personal or study-provided devices for exercise and 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
- Distant metastatic carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 30 days
Participants in the intervention group follow a 30-day preoperative program including virtual instructor-guided cycling-based high-intensity aerobic exercise twice weekly and daily self-directed mindfulness meditation practice. Participants use study-provided devices to exercise, meditate, and log activities.
Twice weekly exercise sessions and daily mindfulness practice
Duration - Day of surgery
Participants undergo radical cystectomy as part of their standard surgical care.
1 surgical visit (in-person)
Duration - 30 days post-operatively
Participants are monitored for 30 days after surgery to assess post-operative complications, health-related quality of life, exercise capacity, mindfulness, and perceived stress.
Follow-up visits over 30 days post-surgery
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
C
Christine Ibilibor
F
Francesca Whitefield
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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