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RECRUITINGINTERVENTIONAL

Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Provision of signed and dated willing to sign a consent form 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 - your organs (liver, kidneys, etc.) are working well enough based on blood tests 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * 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

Treatments Being Tested

BEHAVIORAL

Pre-operative physical exercise

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.

BEHAVIORAL

Pre-operative mindfulness meditation practice

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)

University of Virginia
Charlottesville, Virginia, United States