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

April 1, 2026 updated by: Mayo Clinic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic in Arizona
        • Contact:
        • Principal Investigator:
          • Juliana M. Kling, MD, MPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Screening (FIT, education, questionnaire, patient navigation)
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
Undergo education for colorectal cancer screening
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Fecal Immunochemical Test
Undergo FIT testing
Other Names:
  • FIT
  • iFOBT
  • immunoassay fecal occult blood test
  • immunochemical fecal occult blood test
  • Immunochemical FOBT
  • immunologic fecal occult blood test
Behavioral: Patient Navigation
Undergo patient navigation for positive FIT results
Other Names:
  • Patient Navigator Program
Other: Questionnaire Administration
Complete questionnaire about colorectal cancer screening and healthcare

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
Time Frame: Up to study completion, up to 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Juliana M. Kling, MD, MPH, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2022

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-009729
  • NCI-2022-04529 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • FIT DOM (Other Identifier: Mayo Clinic Women's Health)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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