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Healthy Eating Program for Bladder Cancer
Phase 1
Recruiting
Led By Karen Yeary
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CANCER PATIENT: Did not receive a partial or radical cystectomy
CANCER PATIENT: Does not have a subsequent more advanced bladder cancer diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a healthy eating program to see if it can help improve outcomes for people with bladder cancer. The program includes educational materials and phone support to help people make healthier choices.
Who is the study for?
This trial is for adults diagnosed with early-stage bladder cancer (Tis, Ta, or T1) who live in Western New York and haven't had a cystectomy. They must speak English, have no other recent cancer diagnoses, and understand the study's nature to give informed consent. Excluded are those recently treated with chemo or radiotherapy, unable to consent or follow the protocol, with brain metastases or severe illnesses.Check my eligibility
What is being tested?
The trial tests a behavioral dietary program aimed at improving eating habits and possibly reducing bladder cancer recurrence risk. It includes educational materials, phone calls, and interactive messages as part of the healthy eating program.See study design
What are the potential side effects?
Since this is a dietary intervention focused on education and behavior change rather than medication or invasive procedures, significant side effects are not anticipated. However, participants may experience changes in diet-related symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had surgery to remove part or all of my bladder.
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My bladder cancer has not progressed to a more advanced stage.
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I have been diagnosed with early-stage bladder cancer.
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I have not been diagnosed with any cancer other than bladder cancer in the last year.
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My doctor speaks English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cruciferae intake
Urinary isothiocyanates levels
Secondary outcome measures
Dietary intake
Gene expression
Other outcome measures
Identification of barriers, facilitators, and other process-related measures relevant to informing the implementation of an evidence-based cruciferae intervention within clinical practice
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (educational materials, phone call, phone messages)Experimental Treatment3 Interventions
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.
Group II: Arm B (educational materials, phone call, phone messages)Active Control3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Dietary Intervention
2016
N/A
~70
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,758 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,582 Total Patients Enrolled
Karen YearyPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
64 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or radiotherapy in the last 4 weeks, or 6 weeks for specific drugs, and have recovered from any side effects.I have not had surgery to remove part or all of my bladder.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My bladder cancer has not progressed to a more advanced stage.I am an adult cancer patient who cannot give consent.You live in the Western New York area.I have been diagnosed with early-stage bladder cancer.I have not been diagnosed with any cancer other than bladder cancer in the last year.I speak English.I am 18 years old or older and have cancer.I was diagnosed with bladder cancer between 2016 and now.I understand this study is experimental and I have signed the consent form.My doctor speaks English.I am a child or teenager with cancer.I do not have brain metastases.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (educational materials, phone call, phone messages)
- Group 2: Arm A (educational materials, phone call, phone messages)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment in progress?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently seeking participants and was initially posted on March 30th 2021 before being revised most recently on September 26th 2022. The project requires 100 patients from one location to participate in it."
Answered by AI
Can patients trust that Behavioral Dietary Intervention will not cause them any harm?
"Given the preliminary nature of this trial, there is limited evidence to support safety and efficacy. Therefore, Behavioral Dietary Intervention was allocated a score of 1 on our scale."
Answered by AI
How many participants can register for this research study?
"Affirmative. The trial, which was initially posted on March 30th 2021 and revised most recently on September 26th 2022, is currently recruiting participants according to clinicaltrials.gov data. This medical study requires a total of 100 volunteers at one location."
Answered by AI
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