Purpose

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.

Condition

Eligibility

Eligible Ages
Over 45 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Criteria

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Other: Educational Intervention
    Undergo education for colorectal cancer screening
    Other names:
    • Education for Intervention
    • Intervention by Education
    • Intervention through Education
    • Intervention, Educational
  • Other: Fecal Immunochemical Test
    Undergo FIT testing
    Other names:
    • FIT
    • iFOBT
    • immunoassay fecal occult blood test
    • immunochemical fecal occult blood test
    • Immunochemical FOBT
    • immunologic fecal occult blood test
  • Behavioral: Patient Navigation
    Undergo patient navigation for positive FIT results
    Other names:
    • Patient Navigator Program
  • Other: Questionnaire Administration
    Complete questionnaire about colorectal cancer screening and healthcare

Recruiting Locations

Mayo Clinic in Arizona
Scottsdale, Arizona 85259
Contact:
Yahaira J. Parker
480-574-3171
Parker.Yahaira@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

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

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.