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

NCT06002269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-07-20

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Dietary and Exercise Intervention

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.

Sponsors & Collaborators

Principal Investigators

  • Mary C Playdon, PhD, MPH · University of Utah NUIP Department and Huntsman Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2025-07-08
Completion
2025-07-08

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002269 on ClinicalTrials.gov