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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT05810714
Collaborator
National Institute on Aging (NIA) (NIH)
94
Enrollment
1
Location
3
Arms
2.4
Actual Duration (Months)
39.2
Patients Per Site Per Month

Study Details

Study Description

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 tailored audio and video brochures with the FIT kits may increase CRC screening among adults living in Appalachia, compared to usual care.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Other: Fecal Immunochemical Test
  • Behavioral: Health Education
  • Behavioral: Health Education
  • Other: Scheduled Notification
  • Other: Survey Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Increasing CRC Screening Using Audio and Video Brochures: A Pilot Randomized Controlled Trial
Actual Study Start Date :
Nov 20, 2021
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (FIT, usual care)

Participants receive the FIT kit and usual care on study.

Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy

    • Other: Fecal Immunochemical Test
    Receive FIT kit
    Other Names:
  • FIT
  • iFOBT
  • immunoassay fecal occult blood test
  • immunochemical fecal occult blood test
  • Immunochemical FOBT
  • immunologic fecal occult blood test

    • Other: Survey Administration
    Ancillary studies
    Experimental: Arm II (FIT, audio brochure, reminder)

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

    Other: Fecal Immunochemical Test
    Receive FIT kit
    Other Names:
  • FIT
  • iFOBT
  • immunoassay fecal occult blood test
  • immunochemical fecal occult blood test
  • Immunochemical FOBT
  • immunologic fecal occult blood test

    • Behavioral: Health Education
    Receive audio brochure

    Other: Scheduled Notification
    Receive scheduled reminder
    Other Names:
  • ScheduledNotification

    • Other: Survey Administration
    Ancillary studies
    Experimental: Arm III (FIT, video brochure, reminder)

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

    Other: Fecal Immunochemical Test
    Receive FIT kit
    Other Names:
  • FIT
  • iFOBT
  • immunoassay fecal occult blood test
  • immunochemical fecal occult blood test
  • Immunochemical FOBT
  • immunologic fecal occult blood test

    • Behavioral: Health Education
    Receive video brochure

    Other: Scheduled Notification
    Receive scheduled reminder
    Other Names:
  • ScheduledNotification

    • Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Fecal immunochemical test (FIT) return [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. Will estimate critical parameters with point estimates and 95% confidence intervals and provide a preliminary test of effectiveness on FIT completion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Mira Katz, PhD, MPH, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mira Katz, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05810714
    Other Study ID Numbers:
    • OSU-21213
    • NCI-2022-00144
    • R21AG061496
    First Posted:
    Apr 12, 2023
    Last Update Posted:
    Apr 12, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Apr 12, 2023