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

Description

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

Bladder Cancer, Non-muscle-invasive Bladder Cancer, Muscle-Invasive Bladder Carcinoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Virginia,

Study Record Dates

2025-06