Clinical trial NCT05790850: Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Official title: Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Non-muscle-invasive Bladder Cancer
Muscle-Invasive Bladder Carcinoma
Keywords: Mindfulness
Meditation
Physical Exercise
Pre-habilitation
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Integrated Translational Health Research Institute of Virginia (iTHRIV)
First posted: 2023-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Number of patient-reported days devoted to solitary psychological support
timeFrame: 30 days
measure: Number of patient-reported days devoted to exercise
timeFrame: 30 days
Secondary outcomes:
measure: Post-operative complication rate
timeFrame: 30 days post-operatively
measure: Patient-reported health-related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaire.
timeFrame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
measure: Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET)
timeFrame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
measure: Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS)
timeFrame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
measure: Perceived stress as assessed by the Perceived Stress Scale 10 (PSS 10)
timeFrame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: