Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship

Stage 0a Bladder Cancer AJCC v8 Clinical Trial

Official title:

POW-R Health: Power to Redefine Your Health A Pragmatic Dietary Intervention to Improve Bladder Cancer Survivorship

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548193
• Other study ID #: I 661820
• Secondary ID: NCI-2020-06639I
• Status: Completed
• Phase: Phase 1
• Start date: April 5, 2021
• Est. completion date: April 4, 2024

Study information

• Verified date: April 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 4, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stage 0a Bladder Cancer AJCC v8
• Stage 0is Bladder Cancer AJCC v8
• Stage I Bladder Cancer AJCC v8
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• Behavioral Dietary Intervention
Receive live phone call
• Behavioral Dietary Intervention
Receive IVR phone messages

Other:
• Educational Intervention
Receive educational materials
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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