Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)

Study Overview
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Brief Summary
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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.

Official Title
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Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)

Conditions
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Bladder Cancer, Non-muscle-invasive Bladder Cancer, Muscle-Invasive Bladder Carcinoma

Intervention / Treatment
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* Behavioral: Pre-operative physical exercise
* Behavioral: Pre-operative mindfulness meditation practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual preoperative care prior to radical cystectomy | |
| Experimental: Intervention<br>Preoperative pre-habilitation | Behavioral: Pre-operative physical exercise<br>* 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.<br>Behavioral: Pre-operative mindfulness meditation practice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complication rate | Percentage of patients with a Clavien Grade 3 or higher complications at 30-days post-operatively | 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. | 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. | 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively | 
| Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET) | Maximal oxygen uptake will be measured using a cycle ergometer-based 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) | 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. | 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) | 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. | 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Meditation, Physical Exercise, Pre-habilitation