Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Usual preoperative care prior to radical cystectomy |
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| Experimental: Intervention Preoperative pre-habilitation |
Behavioral: 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.
Behavioral: 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.
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Outcome Measures
Primary Outcome Measures
- 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
- Post-operative complication rate [30 days post-operatively]
Percentage of patients with a Clavien Grade 3 or higher complications at 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]
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.
- 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).
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of signed and dated informed consent form
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Stated willingness to comply with all study procedures and availability for the duration of the study
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Male or female, aged ≥18 years of age
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Good surgical candidate determined by treating surgeon
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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
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Adequate Organ Function per protocol definition
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ECOG performance status ≤2
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Received medical clearance to complete cardiopulmonary exercise testing
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Willing to use the personal or study provided devices for monitoring and performing the exercise routines.
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Fluent in English or Spanish for the EORTC QLQ questionnaire
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No known contraindications to high intensity exercise
Exclusion Criteria:
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Contraindications to participating in aerobic exercise
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Currently participating in an aerobic exercise program
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New onset chest pain nor dyspnea with exertion
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Histologically documented micropapillary or sarcomatoid bladder cancer
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Distant metastatic carcinoma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Virginia | Charlottesville | Virginia | United States | 22903 |
Sponsors and Collaborators
- University of Virginia
- American Cancer Society, Inc.
- Integrated Translational Health Research Institute of Virginia (iTHRIV)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSR210502