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

NCT05447923 | Recruiting

• 3 other identifiers: 21-009729NCI-2022-04529FIT DOM
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Screening (FIT, education, questionnaire, patient navigation)

EXPERIMENTAL

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; Other: Fecal Immunochemical Test; Behavioral: Patient Navigation; Other: Questionnaire Administration

Interventions

Educational Intervention OTHER

Undergo education for colorectal cancer screening

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Screening (FIT, education, questionnaire, patient navigation)

Fecal Immunochemical Test OTHER

Undergo FIT testing

Also known as: FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test, Immunochemical FOBT, immunologic fecal occult blood test

Screening (FIT, education, questionnaire, patient navigation)

Patient Navigation BEHAVIORAL

Undergo patient navigation for positive FIT results

Also known as: Patient Navigator Program

Screening (FIT, education, questionnaire, patient navigation)

Questionnaire Administration OTHER

Complete questionnaire about colorectal cancer screening and healthcare

Screening (FIT, education, questionnaire, patient navigation)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Patient Navigation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Juliana M. Kling, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yahaira J. Parker

CONTACT

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

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 7, 2022
• Study Start: May 22, 2022
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

US (1)