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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| Integrated Translational Health Research Institute of Virginia (iTHRIV) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Usual preoperative care prior to radical cystectomy | |
| Intervention | Experimental | Preoperative pre-habilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-operative physical exercise | Behavioral | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Ibilibor | Contact | 4349240871 | ci5d@virginia.edu | |
| Francesca Whitefield | Contact | 4349240871 | fbw3mg@virginia.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
Summary of trial outcome data through publication or grant reporting requirements.
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|
| Pre-operative mindfulness meditation practice | Behavioral | 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. |
|
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 |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D001519 | Behavior |
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