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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Non-tailored CRC screening brochure; Behavioral: Interactive computer intervention

• Registration Number: NCT00672828
• Lead Sponsor: Indiana University

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-03
• Study First Submitted QC: 2008-05-03
• Study First Posted: 2008-05-06
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-16
• Last Update Posted: 2013-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 693

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-tailored CRC screening brochure	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.
Interactive computer intervention	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.

Primary Outcome Measures

Name	Time	Method
Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion	6 and 15 months post-intervention

Secondary Outcome Measures

Name	Time	Method
Self-reported stage of CRC screening test adoption	Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention	For FOBT, colonoscopy, and sigmoidoscopy, stage of adoption measured as either precontemplation, contemplation, preparation, action, or maintenance.
Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date	1 week post-intervention	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.
Self-reported CRC health beliefs	Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention	Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed.
Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date	1 week post-intervention	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.

Trial Locations

Locations (1)

Indiana University School of Nursing; 🇺🇸 Indianapolis, Indiana, United States