Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
NCT ID: NCT05790850
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-03-30
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
Usual preoperative care prior to radical cystectomy
No interventions assigned to this group
Intervention
Preoperative pre-habilitation
Pre-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.
Pre-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.
Interventions
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Pre-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.
Pre-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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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American Cancer Society, Inc.
OTHER
Integrated Translational Health Research Institute of Virginia (iTHRIV)
UNKNOWN
University of Virginia
OTHER
Responsible Party
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Christine Ibilibor, MD
Assistant Professor
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Christine Ibilibor
Role: primary
Ashley Byrne
Role: backup
Christine Ibilibor, MD
Role: backup
Other Identifiers
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HSR210502
Identifier Type: -
Identifier Source: org_study_id