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

RecruitingNAAges 18 Years - 90 YearsAllUniversity of Virginia
NCT05790850 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Pre-operative physical exercise
  • Pre-operative mindfulness meditation practice
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Where

1 site
University of Virginia
Charlottesville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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