Home-based lifestyle intervention to improve outcomes for bladder cancer patients
A Home-based Lifestyle Intervention for Optimizing Surgical Outcomes Among Urinary Bladder Cancer Patients: the BOOST Study
This study is testing a home-based diet and exercise program called 'The Boost Box' to see if it can help bladder cancer patients have better surgical outcomes and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06002269 on ClinicalTrials.gov |
What this trial studies
This study tests a randomized, controlled intervention aimed at improving surgical outcomes for urinary bladder cancer patients through a home-based diet and physical activity program called 'The Boost Box'. It focuses on addressing barriers to participation in lifestyle changes and evaluates the feasibility and acceptability of this intervention among patients undergoing cystectomy with or without neo-adjuvant chemotherapy. The study will also assess the impact of the intervention on complication rates, nutritional status, weight loss, and quality of life post-surgery. Participants will receive dietetic consultations to monitor their nutritional status before and after surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are newly diagnosed with urinary bladder cancer and are scheduled for cystectomy.
Not a fit: Patients who are not undergoing cystectomy or those with advanced metastatic bladder cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved surgical outcomes and quality of life for bladder cancer patients.
How similar studies have performed: While few dietary interventions have been conducted in this population, the approach of combining diet and exercise is novel and has not been extensively tested in bladder cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients 18 years or older. 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. 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. Exclusion Criteria: 1. Special dietary requirements (i.e., allergies and intolerances, or other clinically prescribed diet). 2. Unable to provide informed consent or read, write, or fill in questionnaires in English
Where this trial is running
Salt Lake City, Utah
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Mary C Playdon, PhD, MPH — University of Utah NUIP Department and Huntsman Cancer Institute
- Study coordinator: Mary C Playdon, PhD, MPH
- Email: mary.playdon@hci.utah.edu
- Phone: 801-213-6264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.