RecruitingNot ApplicableNCT05790850

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


Sponsor

University of Virginia

Enrollment

30 participants

Start Date

Mar 30, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study — called the PRIMER Trial — is testing whether a combination of mindfulness practice and exercise before bladder removal surgery (radical cystectomy) can improve patients' physical fitness and quality of life. Preparing the body and mind before major surgery is called "pre-habilitation," and researchers believe it can lead to better recovery outcomes. **You may be eligible if...** - You are 18 or older - You have been diagnosed with bladder cancer requiring radical cystectomy (bladder removal) - Your surgeon has deemed you a good surgical candidate - You are willing to engage in both an exercise program and mindfulness practices before your surgery - You can communicate in English or Spanish **You may NOT be eligible if...** - You have contraindications to aerobic exercise - You currently participate in a regular aerobic exercise program - You have new chest pain or shortness of breath with exertion - Your bladder cancer is of a rare, aggressive subtype (micropapillary or sarcomatoid) - Your cancer has spread to distant organs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPre-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.

BEHAVIORALPre-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

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NCT05790850


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