COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients: the BOOST Study

Quick Facts

Study Start:2024-06-04
Study Completion:2025-07-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06002269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult patients 18 years or older.
  2. 2. Newly diagnosed urinary bladder cancer patients indicated for cystectomy with or without neo-adjuvant therapy; Treated with surgery at the Huntsman Cancer Institute
  3. 3. Have reliable, consistence access to the internet for study procedures
  1. 1. Special dietary requirements (i.e., allergies and intolerances, or other clinically prescribed diet).
  2. 2. Unable to provide informed consent or read, write, or fill in questionnaires in English

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: University of Utah

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-04
Study Completion Date2025-07-08

Study Record Updates

Study Start Date2024-06-04
Study Completion Date2025-07-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Bladder Cancer
  • Cystectomy
  • Chemotherapy