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Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship

Primary Purpose

Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Behavioral Dietary Intervention

Educational Intervention

Questionnaire Administration

About this trial

This is an interventional supportive care trial for Stage 0a Bladder Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (educational materials, phone call, phone messages)

Arm B (educational materials, phone call, phone messages)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

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.

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).

Full Information

NCT ID

NCT04548193

First Posted

September 9, 2020

Last Updated

May 1, 2023

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04548193

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 5, 2021 (Actual)

Primary Completion Date

April 5, 2024 (Anticipated)

Study Completion Date

April 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A (educational materials, phone call, phone messages)

Arm Type

Experimental

Arm Description

Arm Title

Arm B (educational materials, phone call, phone messages)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Dietary Intervention

Intervention Description

Receive live phone call

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Dietary Intervention

Intervention Description

Receive IVR phone messages

Intervention Type

Other

Intervention Name(s)

Educational Intervention

Other Intervention Name(s)

Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Intervention Description

Receive educational materials

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Urinary isothiocyanates levels

Description

Time Frame

6 months

Title

Cruciferae intake

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Gene expression

Description

Time Frame

6 months

Title

Dietary intake

Description

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).

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Identification of barriers, facilitators, and other process-related measures relevant to informing the implementation of an evidence-based cruciferae intervention within clinical practice

Description

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.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Yeary

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Yeary

Phone

716-845-6231

karen.yeary@roswellpark.org

First Name & Middle Initial & Last Name & Degree

Karen Yeary

12. IPD Sharing Statement

Learn more about this trial

Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship

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