Stage 0a Bladder Cancer AJCC v8Phase 1NCT04548193

Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship

A Phase 1 study testing Behavioral Dietary Intervention, Educational Intervention and Questionnaire Administration in people with Stage 0a Bladder Cancer AJCC v8 and Stage 0is Bladder Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
What is being tested?: Behavioral Dietary Intervention, Educational Intervention and Questionnaire Administration
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 5 Apr 2021to 4 Apr 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Cancer Institute
Buffalo, New York, 14263

Other trials in United States

About this study

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

Read the detailed description

PRIMARY OBJECTIVES:

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:

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:

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.

Conditions: Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
Being tested: Behavioral Dietary Intervention, Educational Intervention, Questionnaire Administration
Medical subject headings: Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral Dietary InterventionBehavioural
Receive live phone call
Behavioral Dietary InterventionBehavioural
Receive IVR phone messages
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive educational materials
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT04548193
Study group	Role	What they receive
Arm A (Experimental arm)	Experimental	6-month Cruciferae intervention Receives: Behavioral: Behavioral Dietary Intervention; Other: Educational Intervention; Other: Questionnaire Administration
Arm B (Control arm)	Active comparator	6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors Receives: Behavioral: Behavioral Dietary Intervention; Other: Educational Intervention; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Urinary Isothiocyanates Levels
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.
Measured: 6 months
Cruciferae Intake Change
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.
Measured: 6 months

Secondary outcomes (2)

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.
Measured: 6 months
Change in Cruciferous Vegetable Intake, Cups/Day
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Apr 20214 Apr 2024

First posted14 Sep 2020
Study start5 Apr 2021
Primary completion4 Apr 2024
Study completion4 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stage 0a Bladder Cancer AJCC v8Studies of the same condition, open and under way.
More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04548193
Sponsor's protocol ID: I 661820
Other IDs: NCI-2020-06639, I 661820, R21CA253910
Status last verified: Aug 2024
First submitted: 9 Sep 2020
Last updated: 28 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Bladder Flat Urothelial Carcinoma In Situ, Non-Muscle Invasive Bladder Urothelial Carcinoma
RecruitingPhase 1/2
In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial
Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8
RecruitingPhase 3
Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8
RecruitingPhase 2
A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscle Invasive Bladder Cancer
Non-Muscle Invasive Bladder Carcinoma, Recurrent Bladder Carcinoma
Active, not recruitingPhase 1
IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer
High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8

All Stage 0a Bladder Cancer AJCC v8 trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: POW-R Health: Power to Redefine Your Health A Pragmatic Dietary Intervention to Improve Bladder Cancer Survivorship
ClinicalTrials.gov ID: NCT04548193
Acronym / sponsor ID: I 661820
Conditions: Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 5 Apr 2021 (actual)
Primary completion: 4 Apr 2024 (actual)
Study completion: 4 Apr 2024 (actual)
First posted: 14 Sep 2020 (actual)
Results: Posted 28 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVE:

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:

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A (Experimental arm)	Experimental	Behavioral: Behavioral Dietary Intervention, Other: Educational Intervention, Other: Questionnaire Administration6-month Cruciferae intervention
Arm B (Control arm)	Active comparator	Behavioral: Behavioral Dietary Intervention, Other: Educational Intervention, Other: Questionnaire Administration6-month fruit and vegetable intervention based on NCI guidelines for cancer survivors

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Behavioral Dietary InterventionReceive live phone call	Behavioural	Arm A (Experimental arm), Arm B (Control arm)
Behavioral Dietary InterventionReceive IVR phone messages	Behavioural	Arm A (Experimental arm), Arm B (Control arm)
Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive educational materials	Other	Arm A (Experimental arm), Arm B (Control arm)
Questionnaire AdministrationAncillary studies	Other	Arm A (Experimental arm), Arm B (Control arm)

Primary outcome

Urinary Isothiocyanates Levels
Time frame: 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
Time frame: 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.

2 secondary outcomes

Gene Expression
Time frame: 6 months
Change in Cruciferous Vegetable Intake, Cups/Day
Time frame: 6 months

Results and safety

Results posted to the registry on 28 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A ( Experimental Arm)	25	22
Arm B (Control Arm)	24	20

Primary outcome: Urinary Isothiocyanates Levels

Time frame: 6 months. Mean (Standard Deviation). Unit: mM

Measure	Arm A (Experimental Arm) n = 22	Arm B (Control Arm) n = 18
Value	10.4 (22.5)	4.3 (14.1)

Arm A (Experimental Arm) vs Arm B (Control Arm): Mean Difference (Final Values): 6.14 (95% CI -5.72 to 17.99), p = 0.28, Wilcoxon (Mann-Whitney)

Population analysed: One patient from Arm B (Control arm) missed baseline and another patient from Arm B (Control arm) missed follow up data. Hence, only 18 patients are included in the final analysis

Primary outcome: Cruciferae Intake Change

Time frame: 6 months. Mean (Standard Deviation). Unit: cups/day

Measure	Arm A (Experimental Arm) n = 22	Arm B (Control Arm) n = 19
Value	0.78 (0.87)	0.058 (1.17)

Arm A (Experimental Arm) vs Arm B (Control Arm): Mean Difference (Final Values): 0.72 (95% CI 0.06 to 1.38), p = .0054, Wilcoxon (Mann-Whitney)

Population analysed: One patient missed follow up date and was not included in the final analysis. Hence only 19 patients are included in the arm B(Control arm) for this analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A ( Experimental Arm)	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Arm B (Control Arm)	0 of 24 (0%)	0 of 24 (0%)	1 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Stage 0a Bladder Cancer AJCC v8

Active, not recruitingPhase 2
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Bladder Flat Urothelial Carcinoma In Situ, Non-Muscle Invasive Bladder Urothelial Carcinoma
RecruitingPhase 1/2
In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial
Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8
RecruitingPhase 3
Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8
RecruitingPhase 2
A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscle Invasive Bladder Cancer
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Active, not recruitingPhase 1
IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karen Yeary principal investigator

Roswell Park Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary Isothiocyanates Levels (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04548193.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.