Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship

Phase 1

Completed

Conditions: Stage I Bladder Cancer AJCC v8
Stage 0a Bladder Cancer AJCC v8
Stage 0is Bladder Cancer AJCC v8

Interventions: Behavioral: Behavioral Dietary Intervention
Other: Educational Intervention
Other: Questionnaire Administration

Registration Number: NCT04548193

Lead Sponsor: Roswell Park Cancer Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (Experimental arm)	Behavioral Dietary Intervention	6-month Cruciferae intervention
Arm A (Experimental arm)	Questionnaire Administration	6-month Cruciferae intervention
Arm B (Control arm)	Behavioral Dietary Intervention	6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors
Arm B (Control arm)	Educational Intervention	6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors
Arm B (Control arm)	Questionnaire Administration	6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors
Arm A (Experimental arm)	Educational Intervention	6-month Cruciferae intervention

Primary Outcome Measures

Name	Time	Method
Urinary Isothiocyanates Levels	6 months	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.
Cruciferae Intake Change	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Gene Expression	6 months	Will be evaluated via ribonucleic acid-sequencing (RNA-seq) as a surrogate for intermediate efficacy, conducted at Roswell Park's Genomics Shared Resource using NextSeq500 platform (Illumina Inc.). Will summarize changes between pre- and post-intervention for both arms and calculate point estimates and their corresponding 95% confidence intervals. Will analyze between-group differences in the change of outcome variables between baseline and post-intervention using ANCOVA.
Change in Cruciferous Vegetable Intake, Cups/Day	6 months	Will be evaluated by three non-consecutive 24-hour dietary recalls (two weekdays, one weekday) conducted by trained staff using the interview-administered Nutrition Data System for Research (NDSR). 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.