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

NCT ID: NCT05447923

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-22

Study Completion Date

2030-06-01

Brief Summary

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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

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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.

Conditions

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Colorectal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Undergo education for colorectal cancer screening

Fecal Immunochemical Test

Intervention Type OTHER

Undergo FIT testing

Patient Navigation

Intervention Type BEHAVIORAL

Undergo patient navigation for positive FIT results

Questionnaire Administration

Intervention Type OTHER

Complete questionnaire about colorectal cancer screening and healthcare

Interventions

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Educational Intervention

Undergo education for colorectal cancer screening

Intervention Type OTHER

Fecal Immunochemical Test

Undergo FIT testing

Intervention Type OTHER

Patient Navigation

Undergo patient navigation for positive FIT results

Intervention Type BEHAVIORAL

Questionnaire Administration

Complete questionnaire about colorectal cancer screening and healthcare

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational FIT iFOBT immunoassay fecal occult blood test immunochemical fecal occult blood test Immunochemical FOBT immunologic fecal occult blood test Patient Navigator Program

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juliana M. Kling, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yahaira J. Parker

Role: CONTACT

480-574-3171

Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Facility Contacts

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Yahaira J. Parker

Role: primary

480-574-3171

Clinical Trials Referral Office

Role: backup

855-776-0015

Related Links

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Other Identifiers

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NCI-2022-04529

Identifier Type: REGISTRY

Identifier Source: secondary_id

FIT DOM

Identifier Type: OTHER

Identifier Source: secondary_id

21-009729

Identifier Type: -

Identifier Source: org_study_id

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