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

NCT05810714 | Completed Results DMC

• 3 other identifiers: OSU-21213NCI-2022-00144R21AG061496
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Arm I (FIT, usual care)

ACTIVE COMPARATOR

Participants receive the FIT kit and usual care on study.

Other: Best Practice; Other: Fecal Immunochemical Test; Other: Survey Administration

Arm II (FIT, audio brochure, reminder)

EXPERIMENTAL

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

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

Arm III (FIT, video brochure, reminder)

EXPERIMENTAL

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

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

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm I (FIT, usual care)

Fecal Immunochemical Test OTHER

Receive FIT kit

Also known as: FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test, Immunochemical FOBT, immunologic fecal occult blood test

Arm I (FIT, usual care); Arm II (FIT, audio brochure, reminder); Arm III (FIT, video brochure, reminder)

Health Education BEHAVIORAL

Receive audio brochure

Arm II (FIT, audio brochure, reminder)

Scheduled Notification OTHER

Receive scheduled reminder

Also known as: ScheduledNotification

Arm II (FIT, audio brochure, reminder); Arm III (FIT, video brochure, reminder)

Survey Administration OTHER

Ancillary studies

Arm I (FIT, usual care); Arm II (FIT, audio brochure, reminder); Arm III (FIT, video brochure, reminder)

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related 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 members. J Rural Health. 2024 Jan;40(1):96-103. doi: 10.1111/jrh.12772. Epub 2023 Jun 9.

  PMID: 37296510 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Results Point of Contact

• Title: Dr. Mira Katz
• Organization: The Ohio State University Comprehensive Cancer Center

Mira.katz@osumc.edu

614-293-6603

Study Officials

• Mira Katz, PhD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 12, 2023
• Study Start: November 20, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)