Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Non-muscle-invasive Bladder Cancer
Conditions
Keywords
Mindfulness, Meditation, Physical Exercise, Pre-habilitation
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.
Interventions
BEHAVIORALPre-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.
BEHAVIORALPre-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.
Sponsors
American Cancer Society, Inc.
Integrated Translational Health Research Institute of Virginia (iTHRIV)
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Post-operative complication rate | 30 days post-operatively | Percentage of patients with a Clavien Grade 3 or higher complications at 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 | 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. |
| 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. |
Countries
United States
Contacts
Primary ContactChristine Ibilibor
Backup ContactFrancesca Whitefield
Outcome results
None listed