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Protect Your Colon™ Decision Aid for Colorectal Cancer Screening
N/A
Recruiting
Led By Christopher V Almario, MD, MSHPM
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post visit
Awards & highlights
Study Summary
This trial will examine how a decision aid, Protect Your Colon™, affects patients' decisions about colorectal cancer screening. It may lead to more people getting tested and increase screening uptake.
Who is the study for?
This trial is for individuals aged 45 to 75 who have never been screened for colorectal cancer (CRC) and are not at high risk due to conditions like inflammatory bowel disease or family history of CRC.Check my eligibility
What is being tested?
The trial is testing 'Protect Your Colon™', a decision aid designed to help patients choose the most suitable CRC screening test based on their values, with the goal of increasing overall screening rates.See study design
What are the potential side effects?
Since 'Protect Your Colon™' is an informational tool rather than a medical treatment, it does not have physical side effects. The focus is on improving communication and informed decision-making.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of completion of a CRC screening test
Secondary outcome measures
Qualitative feedback on details of CRC screening test
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Protect Your Colon™ (Intervention)Experimental Treatment1 Intervention
Patients randomized to Protect Your Colon™ will be directed to go through the website at least 2 days before their clinic appointment. Those who finish the decision aid will then review their personalized report which details their priorities in selecting a screening test as well as the test that best matches their values. Patients will also be encouraged to bring their personalized report with them to the visit to discuss with their doctor. All intervention participants will also receive a reminder via email one day before their scheduled clinic visit. They will be reminded to go through the Protect Your Colon™ website before the clinic visit and to bring their personalized report with them to the visit.
Group II: Usual Care (Control)Active Control1 Intervention
The usual care group will be managed according to the providers' customary practices: CRC screening discussions, if any, are at the discretion of the provider as Cedars-Sinai does not employ a standardized approach. Patients randomized to the control arm will not be sent any materials before their clinic appointment.
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,257 Total Patients Enrolled
9 Trials studying Colorectal Cancer Screening
4,527 Patients Enrolled for Colorectal Cancer Screening
Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,679 Total Patients Enrolled
Christopher V Almario, MD, MSHPMPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 45 and 75 years old.I have never had screening for colorectal cancer.I am not at high risk for colorectal cancer due to conditions like IBD or family history.I do not speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care (Control)
- Group 2: Protect Your Colon™ (Intervention)
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.
Are there any opportunities for volunteers to join this research project?
"According to available information on clinicaltrials.gov, this trial is no longer recruiting participants. The last update was recorded as June 30th 2023, shortly after the study's initial posting of August 1st 2023. Despite being closed for recruitment, there are still 903 other studies accepting patients at present time."
Answered by AI
Does the age criterion of this medical research exclude adults under 30?
"The enrollment parameters for this trial are restricted to individuals aged 45-75."
Answered by AI
Am I eligible to become a participant in this clinical exploration?
"Eligible participants for the trial must have colorectal cancer screening and fall between 45 and 75 years of age. This study is currently in search of 184 individuals."
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