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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colorectal Carcinoma

Intervention / Treatment
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* Other: Best Practice
* Other: Fecal Immunochemical Test
* Behavioral: Health Education
* Behavioral: Health Education
* Other: Scheduled Notification
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (FIT, usual care)<br>Participants receive the FIT kit and usual care on study. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Fecal Immunochemical Test<br>* Receive FIT kit<br>* Other names: immunologic fecal occult blood test;Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (FIT, audio brochure, reminder)<br>Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. | Other: Fecal Immunochemical Test<br>* Receive FIT kit<br>* Other names: immunologic fecal occult blood test;Behavioral: Health Education<br>* Receive audio brochure<br>Other: Scheduled Notification<br>* Receive scheduled reminder<br>* Other names: ScheduledNotification;Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Arm III (FIT, video brochure, reminder)<br>Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study. | Other: Fecal Immunochemical Test<br>* Receive FIT kit<br>* Other names: immunologic fecal occult blood test;Behavioral: Health Education<br>* Receive video brochure<br>Other: Scheduled Notification<br>* Receive scheduled reminder<br>* Other names: ScheduledNotification;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |