Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans

Study Overview
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Brief Summary
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RATIONALE: An interactive computer program may be more effective than a brochure in increasing colorectal cancer screening among African Americans. PURPOSE: This randomized clinical trial is studying an interactive computer program to see how well it works compared with a brochure in increasing colorectal cancer screening among African Americans.

Detailed Description
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OBJECTIVES: Compare rates of participation in fecal occult blood testing and endoscopic screening (colonoscopy or sigmoidoscopy) among African-Americans who receive an interactive computer intervention (ICI) versus a non-tailored colorectal cancer screening brochure. Examine mediators and moderators of intervention effectiveness as depicted in the conceptual model. OUTLINE: This is a multicenter study. Participants are stratified according to site, age (≤ 65 years old vs > 65 years old) and gender. Participants are randomized to one of two arms. Arm I (non-tailored colorectal cancer screening brochure): Participants undergo a baseline interview via telephone and receive a colorectal cancer screening brochure in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months. Arm II (interactive computer intervention [ICI]): Participants undergo a baseline interview via telephone and complete an ICI in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.

Official Title
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Promoting Colon Cancer Screening Among African Americans

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Non-tailored CRC screening brochure
* Behavioral: Interactive computer intervention


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Currently being seen in the primary care clinics of Wishard Memorial Hospital (Indianapolis, IN), Roudebush Veterans Affairs Medical Center (Indianapolis, IN), IU Health Family Medicine Center (Indianapolis, IN) or Norton Louisville Primary Care Clinic (Louisville, KY) African-American who is currently non-adherent to screening guidelines, meeting all of the following criteria: No fecal occult blood test in the past 12 months No sigmoidoscopy in the past 5 years No colonoscopy in the past 10 years Patients with average and increased risk for colorectal cancer are eligible No personal history of colorectal cancer PATIENT CHARACTERISTICS: Participants must have a telephone English-speaking Able to read at a 5th grade reading level No medical condition that prohibits colorectal cancer screening PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 51 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-tailored CRC screening brochure<br>Participants undergo a baseline interview via telephone and receive a non-tailored CRC screening brochure in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months. | Behavioral: Non-tailored CRC screening brochure<br>* Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.<br>|
| Experimental: Interactive computer intervention<br>Participants undergo a baseline interview via telephone and complete an interactive computer intervention in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months. | Behavioral: Interactive computer intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion |  | 6 and 15 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date | Discussion of Fecal Occult Blood Test (FOBT), colonoscopy, and sigmoidoscopy is assessed. Participants report on whether or not an FOBT kit was given to them during this visit. Additionally, participants report on whether or not someone in the doctor's office made an appointment for a colonoscopy or sigmoidoscopy. | 1 week post-intervention | 
| Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date | Medical record documentation of discussion of FOBT, providing participant with an FOBT kit, discussion and/or ordering a colonoscopy, and discussion and/or ordering a sigmoidoscopy is assessed. | 1 week post-intervention | 
| Self-reported CRC health beliefs | Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed. | Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention | 
| Self-reported stage of CRC screening test adoption | For FOBT, colonoscopy, and sigmoidoscopy, stage of adoption measured as either precontemplation, contemplation, preparation, action, or maintenance. | Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer