Promoting Colon Cancer Screening Among African Americans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 693
- Locations
- 1
- Primary Endpoint
- Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 51 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Non-tailored CRC screening brochure
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.
Intervention: Non-tailored CRC screening brochure (Behavioral)
Interactive computer intervention
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.
Intervention: Interactive computer intervention (Behavioral)
Outcomes
Primary Outcomes
Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion
Time Frame: 6 and 15 months post-intervention
Secondary Outcomes
- Self-reported stage of CRC screening test adoption(Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention)
- Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date(1 week post-intervention)
- Self-reported CRC health beliefs(Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention)
- Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date(1 week post-intervention)