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Trial Title:
Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
NCT ID:
NCT05790850
Condition:
Bladder Cancer
Non-muscle-invasive Bladder Cancer
Muscle-Invasive Bladder Carcinoma
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
Mindfulness
Meditation
Physical Exercise
Pre-habilitation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Pre-operative physical exercise
Description:
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.
Arm group label:
Intervention
Intervention type:
Behavioral
Intervention name:
Pre-operative mindfulness meditation practice
Description:
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.
Arm group label:
Intervention
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Virginia
Address:
City:
Charlottesville
Zip:
22903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Ibilibor
Email:
CI5D@virginia.edu
Contact backup:
Last name:
Ashley Byrne
Email:
aeb6q@uvahealth.org
Investigator:
Last name:
Christine Ibilibor, MD
Email:
Principal Investigator
Start date:
March 30, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
University of Virginia
Agency class:
Other
Collaborator:
Agency:
American Cancer Society, Inc.
Agency class:
Other
Collaborator:
Agency:
Integrated Translational Health Research Institute of Virginia (iTHRIV)
Agency class:
Other
Source:
University of Virginia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05790850
