NCT06002269Completed
A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients
A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients: the BOOST Study
Source: ClinicalTrials.gov · Last updated 20 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 15 Aug 2023
- Start date
- 4 Jun 2024
- Primary completion date
- 8 Jul 2025
- Lead sponsor
- University of Utah
- Diseases
- Bladder cancer
- NCT number
- NCT06002269
What you commit to
- Study type: Interventional
- Participants enrolled: 8
- From 4 Jun 2024 to the primary completion date, 8 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Special dietary requirements (i.e., allergies and intolerances, or other clinically prescribed diet).
Other
- Unable to provide informed consent or read, write, or fill in questionnaires in English
Who the study is looking for
- 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
- Inclusion of Individuals across the Lifespan: The proposed trial will enroll 20 adults who have been diagnosed with bladder cancer. The age range of participants to be recruited is 18 years or older. Bladder cancer is generally a disease of older age and is exceedingly rare in children. According to the American Cancer Society, average age at diagnosis is 73.1 Therefore, we are unable to include children in this trial.
- Inclusion of Women, Minorities, and Children: It is anticipated that 20% will be female; 80% male. Racial distribution is projected to be as follows: 97% white, 1% Native Hawaiian or Pacific Islander; 1% American Indian/ Alaska Native; 1% Asian; \<1% Black. Approximately 96% will be Non-Hispanic.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.