Audio and Video Brochures for Increasing Colorectal Cancer Screening Among Adults Living in Appalachia

Colorectal Carcinoma Clinical Trial

Official title:

Increasing CRC Screening Using Audio and Video Brochures: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810714
• Other study ID #: OSU-21213
• Secondary ID: NCI-2022-00144R2
• Status: Completed
• Phase: N/A
• Start date: November 20, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: December 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Other:
• Best Practice
Receive usual care
• Fecal Immunochemical Test
Receive FIT kit

Behavioral:
• Health Education
Receive audio brochure
• Health Education
Receive video brochure

Other:
• Scheduled Notification
Receive scheduled reminder
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Katz ML, Shoben AB, Newell S, Hall C, Emerson B, Gray DM 2nd, Chakraborty S, Reiter PL. Video brochures in a mailed fecal immunochemical test outreach program provide cancer screening information in a user-friendly format for rural Appalachian community m — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants to Return Fecal Immunochemical Test (FIT)	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