Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
PRIMER
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedStudy Start
First participant enrolled
March 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedDecember 16, 2024
December 1, 2024
2.5 years
March 16, 2023
December 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of patient-reported days devoted to solitary psychological support
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
30 days
Number of patient-reported days devoted to exercise
Patient-reported minutes per day devoted to high-intensity exercise during a 30 day period pre-operatively in the pre-habilitation program group
30 days
Secondary Outcomes (5)
Post-operative complication rate
30 days post-operatively
Patient-reported health-related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaire.
4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET)
4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS)
4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Perceived stress as assessed by the Perceived Stress Scale 10 (PSS 10)
4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Study Arms (2)
Control
NO INTERVENTIONUsual preoperative care prior to radical cystectomy
Intervention
EXPERIMENTALPreoperative pre-habilitation
Interventions
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 16, 2023
First Posted
March 30, 2023
Study Start
March 30, 2023
Primary Completion
October 1, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
December 16, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share
Summary of trial outcome data through publication or grant reporting requirements.