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

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05447923
Collaborator
National Cancer Institute (NCI) (NIH)
450
Enrollment
1
Location
1
Arm
24.7
Anticipated Duration (Months)
18.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
  • Other: Fecal Immunochemical Test
  • Behavioral: Patient Navigation
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Colorectal Cancer Screening in Black and Underserved Communities in the Phoenix Metro Area: Addressing Disparities in Cancer Prevention
Actual Study Start Date :
May 11, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. Colorectal cancer disparities seen in people of color and minority populations [Up to study completion, up to 30 days]

      Evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Arizona Scottsdale Arizona United States 85259

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Juliana M Kling, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05447923
    Other Study ID Numbers:
    • 21-009729
    • NCI-2022-04529
    • 21-009729
    • P30CA015083
    First Posted:
    Jul 7, 2022
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Jul 7, 2022