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


N/A
50 Years
75 Years
Open (Enrolling)
Both
Colorectal Neoplasms

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Screening

Outcome Measure:

Up to date colorectal cancer screening status

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Anthony Jerant, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis

Authority:

United States: Institutional Review Board

Study ID:

NCI -1R01CA131386-01A1

NCT ID:

NCT00786747

Start Date:

February 2010

Completion Date:

October 2012

Related Keywords:

  • Colorectal Neoplasms
  • Computer-assisted instruction
  • Health knowledge, attitudes, practice
  • Mass screening
  • Patient acceptance of health care
  • Patient education as topic
  • Primary health care
  • Self-efficacy
  • Neoplasms
  • Colorectal Neoplasms

Name

Location
University of Colorado Denver, Colorado  80217
University of Texas Health Sciences Center San Antonio, Texas  
University of California, Davis Health System Sacramento, California  95817
Sophie Davis School of Biomedical Education, City University of New York, New York City, New York  10031
University of Rochester School of Medicine and Dentistry Rochester, New York  14642