A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients

NCT06002269 | Completed DMC

• 1 other identifier: HCI150155
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer; Cystectomy; Chemotherapy

Keywords

Surgery; Weight Loss; Urinary; Lifestyle; Cystectomy; Malnutrition; Chemotherapy; Diet; Exercise

Outcome Measures

Primary Outcomes (2)

• Feasibility of BOOST Box Intervention

  Feasibility of a novel, peri-operative lifestyle intervention, "The Boost Box", among bladder cancer patients receiving cystectomy with or without neo-adjuvant chemotherapy. Feasibility metrics include: % consented/referred; attrition as a function of time; % questionnaires completed; % meals prepared and consumed. Feasibility criteria: \>70% patients consented and retained; completed all questionnaires; prepared/consumed Boost Box meals ≥5/7 days/week; and adhered to resistance band exercise ≥2 days/week. Fidelity criteria: 90% protocol checklist items delivered as intended.

  From enrollment to the 6-month follow-up survey

• Acceptability of BOOST Box Intervention

  Acceptability of a novel, peri-operative lifestyle intervention, "The Boost Box", among bladder cancer patients receiving cystectomy with or without neo-adjuvant chemotherapy. Acceptability of the intervention delivery and menus/recipes will be evaluated by administering an anonymous questionnaire incorporating both Likert scale questions and space for open-ended responses.

  From enrollment to the 6-month follow-up survey

Secondary Outcomes (4)

• Malnutrition assessment

  mPG-SGA, FAACT, and Short 2012 at baseline and then mPG-SGA and FAACT again six weeks post-surgery. ASA24 during six weeks pre and post-surgery

• Surgical complication rate

  30 and 60 days post-surgery

• Body weight

  From enrollment to the 6-month follow-up survey

• Quality of Life (Physical, social, emotional, functional well-being, and a bladder cancer subscale)

  FACT-BI-Cys used from baseline to the 6-month follow-up survey

Study Arms (2)

BOOST Box Intervention

EXPERIMENTAL

Baseline: Questionnaires (FACT-Bl-Cys, mPG-SGA, Short 2012, FAACT, Godin, TCC), exercise prescription, compensation. Pre-Surgery: Dietitian consultation, at least 3-weeks and up to 6-weeks of Boost Box deliveries and check-ins (nutritional intervention), up to 6 weeks of exercise intervention and logs, ASA Food Record (x2), compensation Post-Surgery: post-surgery surveys once (FACT-Bl-Cys, mPG-SGA, FAACT, Godin), 6 weeks of Boost Box deliveries and check-ins (nutritional intervention), 6 weeks of exercise intervention and logs, weekly hunger check-in, ASA Food Record (x2), Dietitian consultation, compensation. Follow-up (estimated 6 months after baseline) : 6-month questionnaire, compensation. Compensation total: up to $100 via electronic gift card.

Combination Product: Dietary and Exercise Intervention

Usual Care

NO INTERVENTION

Baseline: Questionnaires (FACT-Bl-Cys, mPG-SGA, Short 2012, FAACT, Godin, TCC), compensation. Pre-Surgery: Dietitian consultation, ASA Food Record (x2), compensation. Post-Surgery: post-surgery surveys once (FACT-Bl-Cys, mPG-SGA, FAACT, Godin), Dietitian consultation, ASA Food Record (x2), compensation. Follow-up (estimated 6 months after baseline): 6-month questionnaire, compensation. Compensation total: up to $100 via electronic gift card.

Interventions

Dietary and Exercise Intervention COMBINATION_PRODUCT

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.

BOOST Box Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients 18 years or older.
• Newly diagnosed urinary bladder cancer patients indicated for cystectomy with or without neo-adjuvant therapy; Treated with surgery at the Huntsman Cancer Institute
• Have reliable, consistence access to the internet for study procedures

You may not qualify if:

• Special dietary requirements (i.e., allergies and intolerances, or other clinically prescribed diet).
• Unable to provide informed consent or read, write, or fill in questionnaires in English

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

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MeSH Terms

Conditions

Urinary Bladder Neoplasms; Weight Loss; Malnutrition; Motor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mary C Playdon, PhD, MPH

  University of Utah NUIP Department and Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Dietitians will be masked to study group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: BOOST Box intervention compared with usual care.

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 21, 2023
• Study Start: June 4, 2024
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)