NCT00786747

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

November 5, 2008

Last Update Submit

December 2, 2015

Conditions

Colorectal Neoplasms

Keywords

Computer-assisted instructionHealth knowledge, attitudes, practiceMass screeningPatient acceptance of health carePatient education as topicPrimary health careSelf-efficacy

Outcome Measures

Primary Outcomes (1)

  • Up to date colorectal cancer screening status

    1 year

Secondary Outcomes (5)

  • 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

Study Arms (2)

Personally tailored computer program

EXPERIMENTAL

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

Non-tailored control computer program

ACTIVE COMPARATOR

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

Interventions

Personally tailored computer programBEHAVIORAL

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).

Personally tailored computer program
Non-tailored control computer programBEHAVIORAL

This program provides users with non-tailored information about colorectal cancer screening, in their preferred language (English or Spanish).

Non-tailored control computer program

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California, Davis Health System

Sacramento, California, 95817, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Sophie Davis School of Biomedical Education, City University of New York,

New York, New York, 10031, United States

Location

University of Rochester School of Medicine and Dentistry

Rochester, New York, 14642, United States

Location

University of Texas Health Sciences Center

San Antonio, Texas, 78229, United States

Location

Related Publications (5)

  • 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.

    PMID: 25892503BACKGROUND

  • 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.

    PMID: 21146950BACKGROUND

  • 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.

    PMID: 24821891RESULT

  • 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.

    PMID: 22985627RESULT

  • 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.

    PMID: 25928315RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsBehaviorPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Anthony Jerant, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

February 1, 2010

Primary Completion

October 1, 2011

Study Completion

November 1, 2012

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(5)