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

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.

Study Overview

• Status: Completed
• Conditions: Stage 0a Bladder Cancer AJCC v8; Stage 0is Bladder Cancer AJCC v8; Stage I Bladder Cancer AJCC v8
• Intervention / Treatment: Other: Questionnaire Administration; Other: Educational Intervention; Behavioral: Behavioral Dietary Intervention; Behavioral: Behavioral Dietary Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (educational materials, phone call, phone messages); 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 IVR phone messages over 6 months.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Receive educational materials; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Behavioral Dietary Intervention; Receive live phone call; Behavioral: Behavioral Dietary Intervention; Receive IVR phone messages
Active Comparator: Arm B (educational materials, phone call, phone messages); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Receive educational materials; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Behavioral Dietary Intervention; Receive live phone call; Behavioral: Behavioral Dietary Intervention; Receive IVR phone messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary isothiocyanates levels	Will be measured using high performance liquid chromatography (HPLC)-based cyclocondensation assay. 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 analysis of covariance (ANCOVA).	6 months
Cruciferae intake	Will be assessed using a questionnaire adapted from Thomson et al. to capture both intake and cooking styles. 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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene expression	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.	6 months
Dietary intake	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).	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of barriers, facilitators, and other process-related measures relevant to informing the implementation of an evidence-based cruciferae intervention within clinical practice	Interviews will be audio-recorded, transcribed verbatim, checked for accuracy and entered into a software program for the management of text data (e.g. NVivo 12). Will code transcripts using content analysis. Coding decisions and emergent findings will be discussed until an agreement is reached.	6 months

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Karen Yeary, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Actual): April 4, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: I 661820 (Other Identifier: Roswell Park Cancer Institute); NCI-2020-06639 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R21CA253910 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No