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Colorectal Cancer Screening Program for Underserved Communities

N/A

Recruiting

Led By Juliana M. Kling, MD, MPH

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No current gastrointestinal (GI) or rectal symptoms (such as rectal bleeding)

No first-degree family history of colorectal cancer who were diagnosed under age 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to study completion, up to 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a program to provide free, home-based colorectal cancer screenings to Black and underserved communities in the Phoenix metropolitan area.

Who is the study for?

This trial is for individuals aged 45 or older in the Phoenix area, particularly from Black and underserved communities. Eligible participants should not have a family history of colorectal cancer diagnosed before age 60, no recent GI symptoms, no colonoscopy in the past 5 years, and no FIT test within the last year.

What is being tested?

The study tests if providing free fecal immunochemical testing (FIT), educational materials on colorectal screening, and patient navigation can improve cancer screening rates in these communities.

What are the potential side effects?

Since this trial involves non-invasive interventions like education and FIT tests rather than medication or surgery, side effects are minimal to none. However, discomfort or emotional distress due to discussions about personal health may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have current GI or rectal symptoms.

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No immediate family member had colorectal cancer before 60.

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I have never had colorectal cancer or colon polyps.

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I am 45 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to study completion, up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to study completion, up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to study completion, up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Colorectal cancer disparities seen in people of color and minority populations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Screening (FIT, education, questionnaire, patient navigation)Experimental Treatment4 Interventions

Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Navigation

2017

Completed Phase 2

~38910

0 / 4Eligibility criteria met