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.
I. Develop an evidence-based behavioral intervention to increase cruciferous vegetable
intake, with the goal of attaining desirable urinary isothiocyanates (ITC) levels effective
for anti-cancer activities.
II. Conduct a feasibility pilot of our dietary behavioral intervention through a hybrid I
implementation randomized controlled design in 80 non-muscle invasive bladder cancer (NMIBC)
survivors, where the treatment group (n=40) will receive an evidence-based telephone
intervention to increase cruciferous vegetable intake and the control group (n=40) will
receive a general fruit and vegetable intake intervention based on National Cancer Institute
I. To ascertain the level of gene expression changes in urinary exfoliated epithelial cells
(due to the intervention) as a surrogate for intermediate efficacy.
I. Engage the clinical care providers of patients enrolled in our intervention to ascertain
the barriers and facilitators of intervention implementation within clinical practice through
conducting 20 semi-structured interviews.
AIM I: Develop an evidence-based behavioral intervention using a systematic process
consisting of information gathering, discussion groups, and mock intervention delivery.
AIM II: Patients are randomized to 1 of 2 arms.
ARM A (HEALTHY EATING PROGRAM A): Patients receive mailed educational materials about the
importance of consuming cruciferae, setting healthier eating goals, and the importance of
keeping track of what they eat. Patients also receive one phone call from study staff to make
sure they understood the educational materials received and 11 interactive voice response
(IVR) phone messages over 6 months.
ARM B (HEALTHY EATING PROGRAM B): Patients receive mailed educational materials about general
fruit and vegetable intake, setting healthier eating goals, and the importance of keeping
track of what they eat. Patients also receive one phone call from study staff to make sure
they understood the educational materials received and 11 IVR phone messages over 6 months.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||August 25, 2020||Phase 1||Interventional|
Primary Outcome 1 - Measure: Urinary isothiocyanates levels
Primary Outcome 1 - Time Frame: 6 months
Primary Outcome 2 - Measure: Cruciferae intake
Primary Outcome 2 - Time Frame: 6 months
- 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: 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
- 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
- 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
Minimum Age: N/A
Maximum Age: N/A
Healthy Volunteers: Accepts Healthy Volunteers
Name: Karen Yeary
Role: Principal Investigator
Affiliation: Roswell Park Cancer Institute
|Roswell Park Cancer Institute
Buffalo, New York 14263