Randomized Controlled Trial of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities

Study Overview
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Brief Summary
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The study investigators have developed an interactive multimedia computer program that provides personally tailored education about colorectal cancer screening in the user's preferred language (English or Spanish). In this study, the investigators will examine whether use of the computer program increases the number of Hispanic patients who receive colorectal cancer screening and lessens or eliminates the glaring disparity in screening between Hispanics and non-Hispanic whites.

Detailed Description
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Background: Interactive multimedia computer programs (IMCPs) show promise as a way of delivering personally tailored (PT) information to enhance cognitive mediators of health behavior and improve patient outcomes. However, it is unclear whether PT IMCPs can be deployed in primary care offices to increase cancer screening uptake and eliminate ethnic disparities in uptake by providing PT information in each user's preferred language. Aims/Hypotheses: We will compare changes in colorectal cancer (CRC) screening cognitive mediators (self-efficacy, perceived barriers, and readiness) and uptake resulting from an IMCP - PT to enhance the key cognitive mediators and targeted to patients' self-identified ethnicity - with changes resulting from a non-tailored electronic leaflet control IMCP. The experimental and control IMCPs will each be offered in English and Spanish versions. We hypothesize that, compared with the appropriate control condition (English, Spanish, or both combined): (1) the English version of the PT IMCP will enhance the cognitive mediators of CRC screening behavior for English-speaking Hispanics and non-Hispanics; (2) there will be similarly favorable changes in these mediators for Hispanics using the Spanish version of the PT IMCP; (3) deployment of the PT IMCP will provide evidence of elimination of disparities in CRC screening between Hispanic and non-Hispanic subjects via its relative impact on the cognitive mediators in these groups; and (4) the PT IMCP (English and Spanish combined) will increase CRC screening uptake in Hispanics and non-Hispanics (considered separately) via changes in the cognitive mediators. Methods: Randomized controlled trial of 2 groups, comparing a PT (to the cognitive mediators) CRC screening IMCP offered in both English and Spanish versions and deployed before a primary care office visit with a non-tailored electronic leaflet CRC screening IMCP (control) also offered in both English and Spanish. Screening methods targeted will be fecal occult blood testing, flexible sigmoidoscopy, and colonoscopy. Primary outcomes will be CRC screening uptake, self-efficacy, perceived barriers, and readiness. Implications: Our findings will determine whether an IMCP that is PT to cognitive mediators of screening behavior and deployed in primary care offices prior to previously scheduled visits can activate patients of various ethnicities to undergo CRC screening. They may also suggest a promising, portable method of reducing disparities in CRC (and other) screening uptake between Hispanic and non-Hispanic individuals.

Official Title
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Randomized Controlled Trial of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Behavioral: Personally tailored computer program
* Behavioral: Non-tailored control computer program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receive primary care at one of the participating outpatient study offices Age at or above 50 years Able to read and speak English and/or Spanish Adequate vision, hearing, and hand function to use an IMCP running on a laptop computer via a touch screen interface Have an active telephone Not up to date for CRC screening. Up to date status will be defined as having completed CRC screening via: fecal occult blood test within 2 years; flexible sigmoidoscopy within 5 years; or colonoscopy within 10 years, consistent with national practice guidelines and standards. Exclusion Criteria: Unable to understand the consent form or the telephone screening questionnaire due to cognitive impairment Unable to provide informed consent due to serious acute illness

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personally tailored computer program<br>The experimental computer program provides the user with information about colorectal cancer screening that is tailored to their self-efficacy, readiness, and perceived barriers to undergoing screening, in their preferred language (English or Spanish). | Behavioral: Personally tailored computer program<br>* The experimental computer program provides the user with information about colorectal cancer screening that is tailored to their self-efficacy, readiness, and perceived barriers to undergoing screening, in their preferred language (English or Spanish).<br>|
| Active Comparator: Non-tailored control computer program<br>This program provides non-tailored, generic information about colorectal cancer screening, in the user's preferred language (English or Spanish). | Behavioral: Non-tailored control computer program<br>* This program provides users with non-tailored information about colorectal cancer screening, in their preferred language (English or Spanish).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Up to date colorectal cancer screening status |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Up to date colonoscopy screening status |  | 1 year | 
| Up to date fecal occult blood testing status |  | 1 year | 
| Colorectal cancer screening self-efficacy |  | Immediately after computer program use | 
| Perceived barriers to colorectal cancer screening |  | Immediately after computer program use | 
| Readiness to undergo colorectal cancer screening |  | Immediately after computer program use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computer-assisted instruction, Health knowledge, attitudes, practice, Mass screening, Patient acceptance of health care, Patient education as topic, Primary health care, Self-efficacy