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

Colorectal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447923
• Other study ID #: 21-009729
• Secondary ID: NCI-2022-04529FI
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Other:
• Educational Intervention
Undergo education for colorectal cancer screening
• Fecal Immunochemical Test
Undergo FIT testing

Behavioral:
• Patient Navigation
Undergo patient navigation for positive FIT results

Other:
• Questionnaire Administration
Complete questionnaire about colorectal cancer screening and healthcare

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials