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A Cross-sectional Partnership to Improve Prevention

Primary Purpose

Colorectal Cancer, Prevention

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
On-site Fecal Immunochemical Test (FIT) Kit Distribution
Mailed Fecal Immunochemical Test (FIT) Kit Distribution
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Prevention, Department of motor vehicles, Cross-sectoral partnership, African Americans, Screening

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Department of Motor Vehicles (DMV)Recruiting
  • Douglas County Treasurer's OfficeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Onsite group

Mailing group

Arm Description

The on-site distribution group will receive the Fecal Immunochemical Test (FIT) kits directly while visiting the Department of Motor Vehicles (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 the FIT kit and post-navigation services for positive results.

The mailing group participants will receive an initial letter from the the Nebraska Department of Health and Human Services (NE DHHS) asking whether they are interested in receiving Fecal Immunochemical Test (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 within three weeks of receipt of the FIT kit and post-navigation services in case of positive results.

Outcomes

Primary Outcome Measures

Fecal Immunochemical Test (FIT) kite return rate
Proportion of participants who have completed the screening by returning Fecal Immunochemical Test (FIT) kits

Secondary Outcome Measures

Fecal Immunochemical Test (FIT) kit positive rate
Proportion of participants who have positive Fecal Immunochemical Test (FIT) kit results

Full Information

First Posted
June 5, 2023
Last Updated
October 3, 2023
Sponsor
University of Nebraska
Collaborators
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05903885
Brief Title
A Cross-sectional Partnership to Improve Prevention
Official Title
Using a Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Robert Wood Johnson Foundation

4. Oversight

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
Data Monitoring Committee
No

5. 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 the 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. Participants 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.
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 an 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' strategies (onsite vs. mailing) using the resources from the partner organizations. For the onsite strategy, the investigators will set up a health promotion booth at a selected DMV location to recruit participants face-to-face, and the investigator's research staff will distribute screening kits on-site (n=600). For the mailing strategy, the investigators will collaborate with the Nebraska Department of Health and Human Services (DHHS) to mail out screening kits to eligible participants using DMV Driver's License Database (n=600). All participants will receive 1) a free screening kit with a prepaid return envelope, 2) a 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 the registration form (e.g., name, contact information, race, gender, previous screening history, etc.). Participants' perceptions and beliefs about screening will be collected via an online survey through text message 3 days after participants receive the screening kit. Kit return status and results will be collected via the participant tracking log shared by the key personnel in the partnership. Outcomes (screening completion rate and positive results) will be compared between the onsite and mailing groups, controlling for other covariates (age, gender, race, healthcare access, income, previous screening history, and health beliefs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Prevention
Keywords
Prevention, Department of motor vehicles, Cross-sectoral partnership, African Americans, Screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Onsite group
Arm Type
Experimental
Arm Description
The on-site distribution group will receive the Fecal Immunochemical Test (FIT) kits directly while visiting the Department of Motor Vehicles (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 the FIT kit and post-navigation services for positive results.
Arm Title
Mailing group
Arm Type
Active Comparator
Arm Description
The mailing group participants will receive an initial letter from the the Nebraska Department of Health and Human Services (NE DHHS) asking whether they are interested in receiving Fecal Immunochemical Test (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 within three weeks of receipt of the FIT kit and post-navigation services in case of positive results.
Intervention Type
Other
Intervention Name(s)
On-site Fecal Immunochemical Test (FIT) Kit Distribution
Other Intervention Name(s)
Face-to-face distribution
Intervention Description
Participants will receive home based Fecal Immunochemical Test (FIT) kit directly at the DMV site by the research staff.
Intervention Type
Other
Intervention Name(s)
Mailed Fecal Immunochemical Test (FIT) Kit Distribution
Intervention Description
Participants will receive home based Fecal Immunochemical Test (FIT) kit directly by mailing without any personal (face-to-face) contact.
Primary Outcome Measure Information:
Title
Fecal Immunochemical Test (FIT) kite return rate
Description
Proportion of participants who have completed the screening by returning Fecal Immunochemical Test (FIT) kits
Time Frame
6 months from the date of FIT distribution
Secondary Outcome Measure Information:
Title
Fecal Immunochemical Test (FIT) kit positive rate
Description
Proportion of participants who have positive Fecal Immunochemical Test (FIT) kit results
Time Frame
6 months from the date of FIT distribution

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jungyoon Kim, PhD
Phone
(402) 552-7235
Email
jungyoon.kim@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jungyoon Kim, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Motor Vehicles (DMV)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jungyoon Kim, PhD
Phone
402-552-7235
Email
beatcancer@unmc.edu
Facility Name
Douglas County Treasurer's Office
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jungyoon Kim, PhD
Phone
402-552-7235
Email
beatcancer@unmc.edu

12. IPD Sharing Statement

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A Cross-sectional Partnership to Improve Prevention

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