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Brief Title: 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)


  • Org Study ID: HSR210502
  • Secondary ID: N/A
  • NCT ID: NCT05790850
  • Sponsor: University of Virginia


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.

  • Overall Status
  • Start Date
    March 30, 2023
  • Phase
    Not Applicable
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


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


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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Christine Ibilibor, Ashley Byrne

Phone: 4349240871, 4349240871



Facility Status Contact
Facility: University of Virginia
Charlottesville, Virginia 22903
United States
Status: Recruiting Contact: Contact
Christine Ibilibor

Ashley Byrne

Principal Investigator
Christine Ibilibor, MD