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

Not Applicable

Completed

• Conditions: Colorectal Carcinoma
• Interventions: Other: Fecal Immunochemical Test; Other: Best Practice; Behavioral: Health Education; Other: Survey Administration; Other: Scheduled Notification

• Registration Number: NCT05810714
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

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 Timeline

• Study Start: 2021-11-20
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-12
• Results First Submitted: 2023-10-17
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Results First Posted: 2023-12-05
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (FIT, usual care)	Survey Administration	Participants receive the FIT kit and usual care on study.
Arm III (FIT, video brochure, reminder)	Scheduled Notification	Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Arm II (FIT, audio brochure, reminder)	Fecal Immunochemical Test	Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Arm II (FIT, audio brochure, reminder)	Health Education	Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Arm II (FIT, audio brochure, reminder)	Scheduled Notification	Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Arm I (FIT, usual care)	Best Practice	Participants receive the FIT kit and usual care on study.
Arm I (FIT, usual care)	Fecal Immunochemical Test	Participants receive the FIT kit and usual care on study.
Arm II (FIT, audio brochure, reminder)	Survey Administration	Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Arm III (FIT, video brochure, reminder)	Fecal Immunochemical Test	Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Arm III (FIT, video brochure, reminder)	Health Education	Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Arm III (FIT, video brochure, reminder)	Survey Administration	Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.

Primary Outcome Measures

Name	Time	Method
Number of Participants to Return Fecal Immunochemical Test (FIT)	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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States