Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities

Study Overview
=================
Brief Summary
-----------------
This clinical trial studies disparities involving colorectal cancer prevention and screening in Black and underserved communities in the Phoenix metropolitan area. The Black community is disproportionately impacted by colorectal cancer, with the highest rate of any racial/ethnic group in the United States. There are complex reasons behind these disparities, largely related to socioeconomic factors and healthcare access. Providing access to free, home-based fecal immunochemical testing (FIT), colorectal screening education, and appropriate follow-up to predominantly Black community-based organizations and underserved communities may help to close this gap.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program for this community in Phoenix. OUTLINE: 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. After completion of screening, participants with a positive FIT test are followed up at 2 and 4 weeks after initial outreach to assure participants have received adequate follow up.

Official Title
-----------------
Colorectal Cancer Screening in Black and Underserved Communities in the Phoenix Metro Area: Addressing Disparities in Cancer Prevention

Conditions
-----------------
Colorectal Carcinoma

Intervention / Treatment
-----------------
* Other: Educational Intervention
* Other: Fecal Immunochemical Test
* Behavioral: Patient Navigation
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 45 years of age or older No prior history of colorectal cancer or colon polyps No first-degree family history of colorectal cancer who were diagnosed under age 60 No current gastrointestinal (GI) or rectal symptoms (such as rectal bleeding) Have not undergone a colonoscopy in the last 5 years Have not had a fecal immunochemical test (FIT) test within the last year Participants that attend 4 predominantly African American churches within the Phoenix Community and extend the study opportunity as feasible to other underserved communities in the Phoenix Metro area

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening (FIT, education, questionnaire, patient navigation)<br>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. | Other: Educational Intervention<br>* Undergo education for colorectal cancer screening<br>* Other names: Intervention, Educational;Other: Fecal Immunochemical Test<br>* Undergo FIT testing<br>* Other names: immunologic fecal occult blood test;Behavioral: Patient Navigation<br>* Undergo patient navigation for positive FIT results<br>* Other names: Patient Navigator Program;Other: Questionnaire Administration<br>* Complete questionnaire about colorectal cancer screening and healthcare<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal cancer disparities seen in people of color and minority populations | Evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program. | Up to study completion, up to 30 days |