Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship
POW-R Health: Power to Redefine Your Health A Pragmatic Dietary Intervention to Improve Bladder Cancer Survivorship
3 other identifiers
interventional
49
1 country
1
Brief Summary
This phase I trial investigates how well a healthy eating program works in improving outcomes in patients with bladder cancer. The behavioral dietary program consists of educational materials, live phone calls, and interactive voice response phone messages. Participating in the healthy eating program may improve eating habits and/or reduce the risk of bladder cancer from coming back.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2021
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
September 14, 2020
CompletedStudy Start
First participant enrolled
April 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2024
CompletedResults Posted
Study results publicly available
August 28, 2024
CompletedAugust 28, 2024
August 1, 2024
3 years
September 9, 2020
June 28, 2024
August 2, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Urinary Isothiocyanates Levels
Will be measured using high performance liquid chromatography (HPLC)-based cyclocondensation assay. The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests.
6 months
Cruciferae Intake Change
Will be assessed using a questionnaire adapted from Thomson et al. to capture both intake and cooking styles. The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests.
6 months
Secondary Outcomes (2)
Gene Expression
6 months
Change in Cruciferous Vegetable Intake, Cups/Day
6 months
Study Arms (2)
Arm A (Experimental arm)
EXPERIMENTAL6-month Cruciferae intervention
Arm B (Control arm)
ACTIVE COMPARATOR6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors
Interventions
Receive live phone call
Receive educational materials
Eligibility Criteria
You may qualify if:
- CANCER PATIENT: Age 18 years old or older (no upper limit)
- CANCER PATIENT: English speaking
- CANCER PATIENT: Diagnosed with stage Tis, Ta, or T1 bladder cancer
- CANCER PATIENT: Resides in the Western New York catchment area
- CANCER PATIENT: Did not receive a partial or radical cystectomy
- CANCER PATIENT: Does not have a prior cancer diagnosis within 12 months of their bladder cancer diagnosis
- CANCER PATIENT: Does not have a subsequent more advanced bladder cancer diagnosis
- CANCER PATIENT: For Roswell Park Cancer Registry only: Bladder cancer diagnosed 2016-2018, 2019-current
- CANCER PATIENT: Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
- PHYSICIAN: English speaking
- PHYSICIAN: Physician in a clinic located in the catchment area
- PHYSICIAN: Currently treats bladder cancer patients
You may not qualify if:
- CANCER PATIENT: Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- CANCER PATIENT: Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- CANCER PATIENT: Adults unable to consent
- CANCER PATIENT: Adults unable to complete study measures in English
- CANCER PATIENT: Individuals who are not yet adults (infants, children, teenagers)
- CANCER PATIENT: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- CANCER PATIENT: Unwilling or unable to follow protocol requirements
- PHYSICIAN: Unable to complete the study measures in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roswell Park Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Katy Wang
- Organization
- Roswell Park Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Yeary
Roswell Park Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2020
First Posted
September 14, 2020
Study Start
April 5, 2021
Primary Completion
April 4, 2024
Study Completion
April 4, 2024
Last Updated
August 28, 2024
Results First Posted
August 28, 2024
Record last verified: 2024-08