Mindfulness and exercise program for bladder cancer surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PRIMER trial aims to evaluate the feasibility of a home-based pre-operative program that combines physical exercise and mindfulness meditation for patients scheduled to undergo radical cystectomy due to bladder cancer. This pilot study focuses on improving both the physical and psychological conditioning of patients before surgery. Participants will engage in structured exercise routines and mindfulness practices to enhance their overall well-being and readiness for the surgical procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Study coordinator: Christine Ibilibor
• Email: ci5d@virginia.edu
• Phone: 4349240871

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ureteral stent versus no stent for adults having radical cystectomy with an ileal conduit

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• AI-enhanced blue light cystoscopy for bladder cancer detection

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• Assessing late images in PET-CT for bladder cancer staging

  This study is testing if taking later images during a PET-CT scan can help better identify lymph node involvement in patients with muscle-invasive bladder cancer.

  Recruiting Hopital Foch · Suresnes, Île-de-France Region · NCT06537960

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.