Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05447923

Conditions

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

Interventions

Educational Intervention

Fecal Immunochemical Test

Patient Navigation

Questionnaire Administration

Study Details

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.

Conditions

Colorectal Carcinoma

Study ID

NCT05447923

Start date

May 22, 2022

Status verified date

Apr, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

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 Design

Enrollment

450 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

Educational Intervention

Undergo education for colorectal cancer screening

Fecal Immunochemical Test

Undergo FIT testing

Patient Navigation

Undergo patient navigation for positive FIT results

Questionnaire Administration

Complete questionnaire about colorectal cancer screening and healthcare

Primary outcome measure

  • Colorectal cancer disparities seen in people of color and minority populations [ Time Frame: Up to study completion, up to 30 days ]

Central Contacts and Locations

Central contacts

Yahaira J. Parker

480-574-3171Parker.Yahaira@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Yahaira J. Parker

480-574-3171Parker.Yahaira@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Juliana M. Kling, MD, MPH

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 2, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-02.