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Recruiting

NCT Number: NCT05447923

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

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.

Recruiting

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Undergo education for colorectal cancer screening

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Fecal Immunochemical Test

Other

Undergo FIT testing

Other names: FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test, Immunochemical FOBT, immunologic fecal occult blood test

Patient Navigation

Behavioral

Undergo patient navigation for positive FIT results

Other names: Patient Navigator Program

Questionnaire Administration

Other

Complete questionnaire about colorectal cancer screening and healthcare

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Yahaira J. Parker

CONTACT

[email protected]

480-574-3171

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Jul 7, 2022
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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