NCT04548193CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 28 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 9 Sept 2020
- Start date
- 5 Apr 2021
- Primary completion date
- 4 Apr 2024
- Lead sponsor
- Roswell Park Cancer Institute
- Diseases
- Bladder cancer
- NCT number
- NCT04548193
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 49
- From 5 Apr 2021 to the primary completion date, 4 Apr 2024
- 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.
Prior treatment
- 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
Other illness
- 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
Other
- PHYSICIAN: Unable to complete the study measures in English
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts 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 |
|---|---|---|---|
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.