Clinical trial NCT04548193: Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship
Official title: POW-R Health: Power to Redefine Your Health A Pragmatic Dietary Intervention to Improve Bladder Cancer Survivorship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stage 0a Bladder Cancer AJCC v8
Stage 0is Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-14
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVES:

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 (NCI) guidelines.

SECONDARY OBJECTIVE:

I. To ascertain the level of gene expression changes in urinary exfoliated epithelial cells (due to the intervention) as a surrogate for intermediate efficacy.

EXPLORATORY OBJECTIVE:

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.

OUTLINE:

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Urinary Isothiocyanates Levels
timeFrame: 6 months
measure: Cruciferae Intake Change
timeFrame: 6 months
Secondary outcomes:
measure: Gene Expression
timeFrame: 6 months
measure: Change in Cruciferous Vegetable Intake, Cups/Day
timeFrame: 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Karen Yeary
role: PRINCIPAL_INVESTIGATOR
References: