Bladder Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Estimated Enrollment:

30

Study ID:

NCT05790850

Recruitment Status:

Recruiting

Sponsor:

University of Virginia

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There is 1 Location for this study

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University of Virginia
Charlottesville Virginia, 22903, United States More Info
Christine Ibilibor
Contact
[email protected]
Ashley Byrne
Contact
[email protected]
Christine Ibilibor, MD
Principal Investigator

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Study is for people with:

Bladder Cancer

Estimated Enrollment:

30

Study ID:

NCT05790850

Recruitment Status:

Recruiting

Sponsor:


University of Virginia

How clear is this clinincal trial information?

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