At a glance
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A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients: the BOOST Study
In Brief
A clinical study evaluating Dietary and Exercise Intervention for Bladder Cancer and 2 related conditions. Completed, enrolled 8 participants across 1 site.
Detailed Summary
The purpose of this study is to test a randomized, controlled diet and physical activity intervention designed to be simple and address barriers to participation in lifestyle intervention among 16 urinary bladder cancer patients. Aim 1 is to test the feasibility and acceptability of a novel, peri-operative lifestyle intervention, "The Boost Box", among bladder cancer patients receiving cystectomy with or without neo-adjuvant chemotherapy. Aim 2 is to measure the feasibility of collecting data on the intervention effects on complication rate, nutritional status, weight loss, and quality of life post-surgery among bladder cancer patients receiving cystectomy ± neoadjuvant therapy. Secondarily, we will determine the magnitude of association between study group and outcomes to inform power calculations in a future, well-powered trial. Participants will: * attend two dietetic consultations at baseline and post-surgical recovery where nutritional status will be evaluated with patient-generated subjective global assessment (PG-SGA) * complete baseline questionnaires (TCC, FACT-BI-Cys, Short 2012, FAACT, Godin) * receive weekly BOOST boxes * complete pre-surgery weekly BOOST check ins * complete post-surgery weekly BOOST check ins * complete an ASA food recall pre and post-surgery * complete an exercise familiarization consult * record weekly resistance and aerobic exercise performed at home * complete a 6 month follow-up questionnaire * receive compensation Researchers will compare to a Usual Care group to determine differences that could be attributed to the BOOST Box intervention.
Study Details
Timeline
Interventions
Participants will receive food ingredients and recipes to be made and consumed for each meal, every day for a period of 3-6 weeks before surgery and 6-weeks after surgery. The menu is designed as a high protein, high calorie diet meeting targets for omega-3 fatty acids, vitamin A, and arginine (immunonutrition meal plan). In addition, participants will receive an individualized exercise prescription to be performed at home using theraband resistance bands.