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OpenTrials
Completed

NCT Number: NCT05810714

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

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.

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Fecal Immunochemical Test

Other

Receive FIT kit

Other names: FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test, Immunochemical FOBT, immunologic fecal occult blood test

Health Education

Behavioral

Receive audio brochure

Scheduled Notification

Other

Receive scheduled reminder

Other names: ScheduledNotification

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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