Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
University of Virginia
30 participants
Mar 30, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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 Criteria5
- 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
Interventions
Virtual instructor-guided twice weekly cycling-based high-intensity aerobic exercise program for a total of 30 days. Participants will use a study provided recumbent exercise bike and wristband fitness tracker to exercise and log the number of days they exercise with an instructor and self-directed cycling.
Daily self-directed mindfulness practice involving a guided imagery meditation for a total of 30 days. Participants will use a study provided guided-imagery meditation audio file loaded to a study provided wristband fitness tracker. Participants will log the number of days they listen to the audio file or participate in self-directed solitary psychological support.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05790850