Audio and Video Brochures for Increasing Colorectal Cancer Screening Among Adults Living in Appalachia
NCT ID: NCT05810714
Last Updated: 2023-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2021-11-20
2022-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Arm I (FIT, usual care)
Participants receive the FIT kit and usual care on study.
Best Practice
Receive usual care
Fecal Immunochemical Test
Receive FIT kit
Survey Administration
Ancillary studies
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.
Fecal Immunochemical Test
Receive FIT kit
Health Education
Receive audio brochure
Scheduled Notification
Receive scheduled reminder
Survey Administration
Ancillary studies
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.
Fecal Immunochemical Test
Receive FIT kit
Health Education
Receive video brochure
Scheduled Notification
Receive scheduled reminder
Survey Administration
Ancillary studies
Interventions
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Best Practice
Receive usual care
Fecal Immunochemical Test
Receive FIT kit
Health Education
Receive audio brochure
Health Education
Receive video brochure
Scheduled Notification
Receive scheduled reminder
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
50 Years
64 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Mira Katz
Principal Investigator
Principal Investigators
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Mira Katz, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2022-00144
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-21213
Identifier Type: -
Identifier Source: org_study_id