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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Behavioral: Personally tailored computer program; Behavioral: Non-tailored control computer program

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.

• Study Type: Interventional
• Enrollment (Actual): 1164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis Health System
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • New York
    • New York City, New York, United States, 10031
      • Sophie Davis School of Biomedical Education, City University of New York,
    • Rochester, New York, United States, 14642
      • University of Rochester School of Medicine and Dentistry
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: University of Rochester; City University of New York, School of Public Health
• Investigators: Principal Investigator: Anthony Jerant, MD, University of California, Davis

Publications and helpful links

General Publications

• Jerant A, Sohler N, Fiscella K, Franks B, Franks P. Tailored interactive multimedia computer programs to reduce health disparities: opportunities and challenges. Patient Educ Couns. 2011 Nov;85(2):323-30. doi: 10.1016/j.pec.2010.11.012. Epub 2010 Dec 13.
• Sohler NL, Jerant A, Franks P. Socio-psychological factors in the Expanded Health Belief Model and subsequent colorectal cancer screening. Patient Educ Couns. 2015 Jul;98(7):901-7. doi: 10.1016/j.pec.2015.03.023. Epub 2015 Apr 8.
• Jerant A, Kravitz RL, Sohler N, Fiscella K, Romero RL, Parnes B, Tancredi DJ, Aguilar-Gaxiola S, Slee C, Dvorak S, Turner C, Hudnut A, Prieto F, Franks P. Sociopsychological tailoring to address colorectal cancer screening disparities: a randomized controlled trial. Ann Fam Med. 2014 May-Jun;12(3):204-14. doi: 10.1370/afm.1623.
• Jerant A, Kravitz RL, Fiscella K, Sohler N, Romero RL, Parnes B, Aguilar-Gaxiola S, Turner C, Dvorak S, Franks P. Effects of tailored knowledge enhancement on colorectal cancer screening preference across ethnic and language groups. Patient Educ Couns. 2013 Jan;90(1):103-10. doi: 10.1016/j.pec.2012.08.017. Epub 2012 Sep 15.
• Jerant A, To P, Franks P. The effects of tailoring knowledge acquisition on colorectal cancer screening self-efficacy. J Health Commun. 2015;20(6):697-709. doi: 10.1080/10810730.2015.1018562. Epub 2015 Apr 30.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 5, 2008
• First Submitted That Met QC Criteria: November 5, 2008
• First Posted (Estimate): November 6, 2008

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Primary health care; Self-efficacy; Mass screening; Patient acceptance of health care; Patient education as topic; Computer-assisted instruction; Health knowledge, attitudes, practice
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NCI -1R01CA131386-01A1; ARRA CA13138602S1 (Other Grant/Funding Number: American Reinvestment and Recovery Act supplement)