Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
- Conditions
- Muscle-Invasive Bladder CarcinomaBladder CancerNon-muscle-invasive Bladder Cancer
- Interventions
- Behavioral: Pre-operative physical exerciseBehavioral: Pre-operative mindfulness meditation practice
- Registration Number
- NCT05790850
- Lead Sponsor
- University of Virginia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Pre-operative physical exercise Preoperative pre-habilitation Intervention Pre-operative mindfulness meditation practice Preoperative pre-habilitation
- Primary Outcome Measures
Name Time Method Number of patient-reported days devoted to solitary psychological support 30 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 exercise 30 days Patient-reported minutes per day devoted to high-intensity exercise during a 30 day period pre-operatively in the pre-habilitation program group
- Secondary Outcome Measures
Name Time Method Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS) 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively The Mindfulness Awareness Attention Scale (MAAS) is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. Total scores range from 0 to 6; higher scores indicate higher dispositional mindfulness.
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 The EORTC QLQ BLM 30 consists of 30 questions developed to assess the quality of life of cancer patients. It incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. The questionnaire was designed to be cancer-specific, multidimensional in structure, appropriate for self-administration, and applicable across a range of cultural settings. All of the scales and single-item measures range in score from 0 to 100. A higher score represents higher symptomatology in each respective domain.
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 the Perceived Stress Scale 10 (PSS 10) is a 10-item survey that captures the respondent's stress level in the past month and uses a Likert scale to assess different domains of stress. Individual scores on the PSS 10 can range from 0 to 40 with higher scores indicating higher perceived stress.
Post-operative complication rate 30 days post-operatively Percentage of patients with a Clavien Grade 3 or higher complications at 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 Maximal oxygen uptake will be measured using a cycle ergometer-based cardiopulmonary exercise testing (CPET).
Trial Locations
- Locations (1)
University of Virginia
🇺🇸Charlottesville, Virginia, United States