RCT of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Rochester
The City University of New York
Information provided by (Responsible Party):
Anthony F. Jerant, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00786747
First received: November 5, 2008
Last updated: April 24, 2012
Last verified: April 2012

November 5, 2008
April 24, 2012
February 2010
October 2011   (final data collection date for primary outcome measure)
Up to date colorectal cancer screening status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00786747 on ClinicalTrials.gov Archive Site
  • Up to date colonoscopy screening status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Up to date fecal occult blood testing status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Colorectal cancer screening self-efficacy [ Time Frame: Immediately after computer program use ] [ Designated as safety issue: No ]
  • Perceived barriers to colorectal cancer screening [ Time Frame: Immediately after computer program use ] [ Designated as safety issue: No ]
  • Readiness to undergo colorectal cancer screening [ Time Frame: Immediately after computer program use ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
RCT of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities
Randomized Controlled Trial of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities

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.

  • 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Colorectal Neoplasms
  • Behavioral: Personally tailored computer program
    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: Non-tailored control computer program
    This program provides users with non-tailored information about colorectal cancer screening, in their preferred language (English or Spanish).
  • Experimental: Personally tailored computer program
    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).
    Intervention: Behavioral: Personally tailored computer program
  • Active Comparator: Non-tailored control computer program
    This program provides non-tailored, generic information about colorectal cancer screening, in the user's preferred language (English or Spanish).
    Intervention: Behavioral: Non-tailored control computer program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1344
October 2012
October 2011   (final data collection date for primary outcome measure)

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: FOBT within 2 years; FS 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
Both
50 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00786747
NCI -1R01CA131386-01A1, ARRA CA13138602S1
No
Anthony F. Jerant, University of California, Davis
University of California, Davis
  • University of Rochester
  • The City University of New York
Principal Investigator: Anthony Jerant, MD University of California, Davis
University of California, Davis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP