Audio and Video Brochures for Increasing Colorectal Cancer Screening Among Adults Living in Appalachia
December 4, 2023 updated by: Mira Katz, Ohio State University Comprehensive Cancer Center
Increasing CRC Screening Using Audio and Video Brochures: A Pilot Randomized Controlled Trial
This clinical trial compares audio brochures and video brochures to usual care for increasing colorectal cancer (CRC) screening among adults living in Appalachia.
Adults living in rural Appalachia experience increased rates of CRC, possibly due to the unique barriers to screening this population faces, such as lower socioeconomic status, limited health literacy, and less access to healthcare.
The fecal immunochemical test (FIT) is a common CRC screening technique which allows individuals to complete the test at home and mail the kit back.
A limitation of the current process for FIT screening outreach is that the instruction materials are heavy in text and not appropriate for individuals with limited health literacy.
The audio and video brochures used in this clinical trial are instruction materials that have been specially designed to be appropriate for individuals of all health literacy levels.
Providing these audio and video brochures with the FIT kits may increase CRC screening among adults living in Appalachia, compared to usual care.
Study Overview
Status
Completed
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. Conduct a pilot study of the two developed mail-based FIT outreach interventions versus (vs.) mailed usual care materials to establish acceptability and obtain preliminary efficacy data on increasing CRC screening.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM I: Participants receive the FIT kit and usual care on study.
ARM II: Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study.
ARM III: Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Mid-life men and women (50-64 years old)
- Live in Appalachia
- Had a medical visit in the past two years
- Are at average-risk for CRC (no history of CRC, polyps, inflammatory bowel disease, family history of CRC or hereditary CRC syndromes)
- Are not within CRC screening guidelines (no fecal occult blood test/FIT in the past year; flexible sigmoidoscopy in past five years; colonoscopy in past ten years)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm I (FIT, usual care)
Participants receive the FIT kit and usual care on study.
|
Receive usual care
Other Names:
Ancillary studies
Receive FIT kit
Other Names:
|
|
Experimental: Arm II (FIT, audio brochure, reminder)
Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study.
|
Ancillary studies
Receive FIT kit
Other Names:
Receive audio brochure
Receive video brochure
Receive scheduled reminder
Other Names:
|
|
Experimental: Arm III (FIT, video brochure, reminder)
Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.
|
Ancillary studies
Receive FIT kit
Other Names:
Receive audio brochure
Receive video brochure
Receive scheduled reminder
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants to Return Fecal Immunochemical Test (FIT)
Time Frame: At 2 months
|
Will estimate FIT return using proportions for each study group.
Both comparisons (each intervention compared to control) will be a two-sample test of proportions (intent-to-treat analysis) using a one-sided alpha of 0.1 due to the preliminary nature of the study.
|
At 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mira Katz, PhD, MPH, Ohio State University Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2021
Primary Completion (Actual)
February 1, 2022
Study Completion (Actual)
February 1, 2022
Study Registration Dates
First Submitted
March 31, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Actual)
April 12, 2023
Study Record Updates
Last Update Posted (Estimated)
December 5, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-21213
- NCI-2022-00144 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R21AG061496 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.