RCT of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of California, Davis.
Recruitment status was  Active, not recruiting
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
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
Behavioral: Personally tailored computer program
Behavioral: Non-tailored control computer program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Randomized Controlled Trial of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Up to date colorectal cancer screening status [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1344
Study Start Date: February 2010
Estimated Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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).
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).
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).

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786747

Locations
United States, California
University of California, Davis Health System
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, New York
Sophie Davis School of Biomedical Education, City University of New York,
New York City, New York, United States, 10031
University of Rochester School of Medicine and Dentistry
Rochester, New York, United States, 14642
United States, Texas
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
University of California, Davis
University of Rochester
The City University of New York
Investigators
Principal Investigator: Anthony Jerant, MD University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: Anthony F. Jerant, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00786747     History of Changes
Other Study ID Numbers: NCI -1R01CA131386-01A1, ARRA CA13138602S1
Study First Received: November 5, 2008
Last Updated: April 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Computer-assisted instruction
Health knowledge, attitudes, practice
Mass screening
Patient acceptance of health care
Patient education as topic
Primary health care
Self-efficacy

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014