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

The Ohio State University

Status: Completed

Conditions: Colorectal Carcinoma

Treatments: Other: Survey Administration; Other: Best Practice; Other: Fecal Immunochemical Test; Other: Scheduled Notification; Behavioral: Health Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05810714

NCI-2022-00144 (Registry Identifier)

R21AG061496 (U.S. NIH Grant/Contract)

OSU-21213

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 50 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 3 patient groups

Arm I (FIT, usual care)

Active Comparator group

Description:

Participants receive the FIT kit and usual care on study.

Treatment:

Other: Survey Administration

Other: Fecal Immunochemical Test

Other: Best Practice

Arm II (FIT, audio brochure, reminder)

Experimental group

Description:

Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study.

Treatment:

Other: Survey Administration

Other: Scheduled Notification

Other: Fecal Immunochemical Test

Behavioral: Health Education

Behavioral: Health Education

Arm III (FIT, video brochure, reminder)

Experimental group

Description:

Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.

Treatment:

Other: Survey Administration

Other: Scheduled Notification

Other: Fecal Immunochemical Test

Behavioral: Health Education

Behavioral: Health Education