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

Post-operative complication rate

Percentage of patients with a Clavien Grade 3 or higher complications at 30-days post-operatively

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively