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A Cross-sectional Partnership to Improve Prevention

Sponsor
University of Nebraska (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05903885
Collaborator
Robert Wood Johnson Foundation (Other)
1,200
Enrollment
2
Arms
29
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is a non-randomized, 2-arm clinical trial comparing the effectiveness of two strategies for distributing FIT (fecal immunochemical test) kits in a community-based colorectal cancer screening program targeting African Americans (AAs). The main questions this study aims to answer are:

  • Does on-site distribution of FIT kits result in higher return rates compared to direct mailing?

  • Which distribution strategy (onsite vs. direct mailing) is a more cost-effective approach for increasing colorectal cancer screening rates among underserved populations?

Participants in the study will be African Americans who are eligible for colorectal cancer screening. They will be assigned to one of two groups: the on-site distribution group or the direct mailing group. In the on-site distribution group, participants will be given FIT kits at a designated Department of Motor Vehicle (DMV) service location. In the direct mailing group, participants will receive the FIT kits through the mail using the DMV database

Condition or Disease Intervention/Treatment Phase
  • Other: On-site FIT Distribution
  • Other: Mailed FIT Distribution
 N/A

Detailed Description

African Americans (AAs) face racial disparities in colorectal cancer (CRC), with higher incidence and mortality rates, as well as lower screening rates. To address this gap and improve CRC screening rates among AAs, this study will use evidence-based, community-based intervention program partnering with multiple cross-sectoral organizations, such as DMV, to recruit AAs who are eligible for CRC screening. This study will test different 'distribution' strategy (onsite vs. mailing) using the resources from the partner organizations. For onsite strategy, we will set up a health promotion booth at a selected DMV location to recruit participants face-to-face and our research staff will distribute screening kits on site (n=600). For mailing strategy, we will collaborate with Nebraska Department of Health and Human Services (DHHS) to mailing out screening kits to eligible participants using DMV Drivers License Database (n=600). All participants will receive 1) a free screening kit with a prepaid return envelope, 2) tailored educational brochure, 3) reminder text/calls, and 4) post navigation services in case of positive results. Fecal Immunochemical Test (FIT) will be used. Kits are returned to a designated lab location for testing, and test results will be mailed to participants within 14-21 days. Upon consent, participants demographic and screening related information will be collected via registration form (e.g., name, contact information, race, gender, previous screening history, etc.). Participants perceptions and beliefs about screening will be collected via online survey through text message 3 days after participants received the screening kit. Kit return status and results will be collected via participant tracking log shared by the key personnel in the partnership. Outcomes (screening completion rate and positive results) will be compared between onsite and mailing group, controlling for other covariates (age, gender, race, health care access, income, previous screening history, and health beliefs).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The on-site distribution (face-to-face) group will receive FIT kits at a designated location (DMV) distributed by a research staff , while the direct mailing group will receive FIT kits through the mail (no physical contact) using the DMV database. All the other conditions are the same for both group except the distribution strategy. FIT return rate will be compared between onsite group and mailing group.The on-site distribution (face-to-face) group will receive FIT kits at a designated location (DMV) distributed by a research staff , while the direct mailing group will receive FIT kits through the mail (no physical contact) using the DMV database. All the other conditions are the same for both group except the distribution strategy. FIT return rate will be compared between onsite group and mailing group.
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Using a Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Jan 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Onsite group

The on-site distribution group will receive the FIT kits directly while visiting the DMV location. Participants in the on-site group will be guided through the process of receiving the FIT kits by trained staff present at the designated location. They will be given instructions on collecting the stool sample and using the FIT kit properly. They will also be given a tailored educational brochure, reminder text messages and phone calls within 3 weeks of the receipt of FIT kit, and post navigation services for positive results.

Other: On-site FIT Distribution
Participants will receive home based stool test (FIT) directly at the DMV site by the research staff.
Other Names:
  • Face-to-face distribution

    		•
    Active Comparator: Mailing group

    The mailing group participants will receive an initial letter from the NE DHHS asking whether they are interested in receiving FIT packets. For those who responded yes, NE DHHS will send FIT kits on behalf of the research team. These participants will receive the FIT kits mailed to their provided addresses using the DMV database. Participants in the mailing group will receive the FIT kits by mail along with detailed instructions on how to collect the stool sample and use the kit. The mailing group will also receive a tailored educational brochure, reminder text messages and phone calls in three weeks of receipt of FIT kit, and post navigation services in case of positive results.

    Other: Mailed FIT Distribution
    Participants will receive home based stool test (FIT) directly by mailing without any personal (face-to-face) contact.

    Outcome Measures

    Primary Outcome Measures

    1. FIT return rate [6 months from the date of FIT distribution]

      Proportion of participants who have completed the screening by returning FIT kits

    Secondary Outcome Measures

    1. FIT positive rate [6 months from the date of FIT distribution]

      Proportion of participants who have positive FIT results

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Self-identification as Black or African American.

    • Age between 45 and 75 years.

    • Not up-to-date with colorectal cancer (CRC) screening per guidelines

    • Willingness to provide contact information for follow-up

    • Ability to speak, read, and write English

    • Current residency in Douglas County, NE.

    Exclusion Criteria:

    • Individuals with a personal history of colorectal cancer (CRC).

    • Individuals with a personal history of adenomas (precancerous polyps) or inflammatory bowel disease.

    • Individuals with a family history of colorectal cancer (CRC).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Nebraska
    • Robert Wood Johnson Foundation

    Investigators

    • Principal Investigator: Jungyoon Kim, University of Nebraska

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jungyoon Kim, Assistant Professor, University of Nebraska
    ClinicalTrials.gov Identifier:
    NCT05903885
    Other Study ID Numbers:
    • 0115-23-EP
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Jungyoon Kim, Assistant Professor, University of Nebraska
    Prevention
    Department of motor vehicles
    Cross-sectoral partnership
    African Americans
    Screening
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Jun 15, 2023