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PRIMER Trial: Mindfulness and Exercise for Bladder Cancer Surgery

The PRIMER trial is studying if a home-based program of physical exercise and mindfulness meditation can help patients prepare for radical cystectomy (surgery to remove the bladder) for bladder cancer. This program, called pre-habilitation, aims to improve your physical and mental well-being before surgery. You would participate in virtual instructor-guided cycling exercise twice a week and daily self-directed mindfulness meditation for 30 days. Researchers want to see how many days participants devote to exercise and psychological support. This small study is open to adults aged 18 to 90 who are good surgical candidates with certain types of bladder cancer. The current status of the study is unclear, and it plans to enroll 30 participants.

Study design
This is an interventional pilot study planning to enroll 30 participants. It is not specified if it is randomized or blinded.
What's involved
You would participate in a 30-day program involving twice-weekly virtual exercise and daily self-directed mindfulness meditation, using provided equipment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 30 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05790850

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

Recruiting
NAAges 18–90InterventionalSupportive care
University of Virginia
~30 participants
Updated 2024-12-16 on ClinicalTrials.gov
What's tested:Pre-operative physical exercisePre-operative mindfulness meditation practice

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patient-reported days devoted to solitary psychological support
Measured over 30 days
+1 more outcome measured

Conditions

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

Explore related trials

Bladder CarcinomaMuscle Invasive Bladder CarcinomaNon-Muscle Invasive Bladder Carcinoma

NCT05790850

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Virginia

    Charlottesville, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Christine Ibilibor
[email protected]
4349240871
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of patient-reported days devoted to solitary psychological support30 days

    Patient-reported days devoted to self-directed solitary psychological support related to cancer treatment during a 30 day period pre-operatively in the pre-habilitation program group

  • Number of patient-reported days devoted to exercise30 days

    Patient-reported minutes per day devoted to high-intensity exercise during a 30 day period pre-operatively in the pre-habilitation program group