This phase II trial is being done to develop and test a healthy eating program to reduce cancer recurrence (cancer that has come back after a period of improvement) and/or progression (cancer that is growing, spreading, or getting worse) in patients with non-muscle invasive bladder cancer (NMIBC). Researchers want to better understand how incorporating more cruciferous vegetables in the diet may reduce the risk of cancer recurrence in men and women diagnosed with early-stage bladder cancer and compare whether different types of healthy eating programs can improve bladder cancer outcomes. POW-R Health is a behavioral dietary intervention designed to modestly increase cruciferous vegetable (cruciferae) intake in patients. Cruciferous vegetables, such as cabbage, kale and broccoli, contain phytochemicals known as isothiocyanates (ITCs). Dietary ITCs exert potent anticancer activities against bladder cancer and can be rapidly metabolized, delivered to the bladder, and concentrated in the urine. Participating in the healthy eating program may reduce bladder cancer recurrence or progression in patients with NMIBC.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06733363.
Locations matching your search criteria
United States
New York
Buffalo
Roswell Park Cancer InstituteStatus: Active
Contact: Karen Yeary
Phone: 716-845-6231
PRIMARY OBJECTIVES:
I. Develop a maintenance component to add onto our POW-R Health intervention (POW-R Health Only/Core) to create POW-R Health + Maintenance.
II. Assess the efficacy of POW-R Health + Maintenance compared to POW-R Health Only/Core using a 2-group randomized controlled trial (RCT) design in 344 participants on the primary outcome of urinary ITC.
SECONDARY OBJECTIVE:
I. Assess the efficacy of POW-R Health + Maintenance compared to POW-R Health Only/Core on the secondary outcome of cruciferae intake.
EXPLORATORY OBJECTIVES:
I. Conduct a detailed chart review to assess bladder cancer treatment information, and recurrence and progression outcomes at 24 months post enrollment.
II. Supplement chart review by linking to the New York Statewide Planning and Research Cooperative System (SPARCS) database to verify and/or provide bladder cancer treatment information, and recurrence and progression outcomes.
OUTLINE:
ADAPTATION: Community Advisor Board (CAB) members participate in maintenance phase development discussion over 1 hour up to 3 times on study.
RCT: Patients are randomized to 1 of 2 arms.
ARM I (POW-R Health Only/Core): Patients receive educational materials about the benefits of incorporating more cruciferous vegetables in their diet on study. Patients then participate in a live phone call over 30 minutes to verify understanding of the educational information. Patients then receive interactive voice response (IVR) phone messages weekly for 3 weeks, then bi-weekly until 6 months in order to collect information about how many vegetables they consumed the previous week. Patients also undergo urine sample collection on study.
ARM II (POW-R Health Only/Core + Maintenance): Patients receive educational materials about the benefits of incorporating more cruciferous vegetables in their diet on study. Patients then participate in a live phone call over 30 minutes to verify understanding of the educational information. Patients then receive IVR phone messages weekly for 3 weeks, then bi-weekly until 6 months in order to collect information about how many vegetables they consumed the previous week. Patients then receive live phone calls monthly for 18 months to monitor progress, answer questions, and explore coping strategies, as well as receive educational newsletters monthly for 18 months. Patients also undergo urine sample collection on study.
After completion of study intervention, patients in Arm I are followed up at 6 and 24 months.
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorKaren Yeary
