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

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personally tailored computer program
Non-tailored control computer program
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Neoplasms focused on measuring Computer-assisted instruction, Health knowledge, attitudes, practice, Mass screening, Patient acceptance of health care, Patient education as topic, Primary health care, Self-efficacy

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, Davis Health System
  • University of Colorado
  • Sophie Davis School of Biomedical Education, City University of New York,
  • University of Rochester School of Medicine and Dentistry
  • University of Texas Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personally tailored computer program

Non-tailored control computer program

Arm Description

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).

This program provides non-tailored, generic information about colorectal cancer screening, in the user's preferred language (English or Spanish).

Outcomes

Primary Outcome Measures

Up to date colorectal cancer screening status

Secondary Outcome Measures

Up to date colonoscopy screening status
Up to date fecal occult blood testing status
Colorectal cancer screening self-efficacy
Perceived barriers to colorectal cancer screening
Readiness to undergo colorectal cancer screening

Full Information

First Posted
November 5, 2008
Last Updated
December 2, 2015
Sponsor
University of California, Davis
Collaborators
University of Rochester, City University of New York, School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT00786747
Brief Title
Randomized Controlled Trial of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities
Official Title
Randomized Controlled Trial of Tailored Interactive Multimedia to Reduce Colorectal Cancer Screening Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis
Collaborators
University of Rochester, City University of New York, School of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Computer-assisted instruction, Health knowledge, attitudes, practice, Mass screening, Patient acceptance of health care, Patient education as topic, Primary health care, Self-efficacy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personally tailored computer program
Arm Type
Experimental
Arm Description
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).
Arm Title
Non-tailored control computer program
Arm Type
Active Comparator
Arm Description
This program provides non-tailored, generic information about colorectal cancer screening, in the user's preferred language (English or Spanish).
Intervention Type
Behavioral
Intervention Name(s)
Personally tailored computer program
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Non-tailored control computer program
Intervention Description
This program provides users with non-tailored information about colorectal cancer screening, in their preferred language (English or Spanish).
Primary Outcome Measure Information:
Title
Up to date colorectal cancer screening status
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Up to date colonoscopy screening status
Time Frame
1 year
Title
Up to date fecal occult blood testing status
Time Frame
1 year
Title
Colorectal cancer screening self-efficacy
Time Frame
Immediately after computer program use
Title
Perceived barriers to colorectal cancer screening
Time Frame
Immediately after computer program use
Title
Readiness to undergo colorectal cancer screening
Time Frame
Immediately after computer program use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Jerant, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Sophie Davis School of Biomedical Education, City University of New York,
City
New York City
State/Province
New York
ZIP/Postal Code
10031
Country
United States
Facility Name
University of Rochester School of Medicine and Dentistry
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25892503
Citation
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.
Results Reference
background
PubMed Identifier
21146950
Citation
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.
Results Reference
background
PubMed Identifier
24821891
Citation
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.
Results Reference
result
PubMed Identifier
22985627
Citation
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.
Results Reference
result
PubMed Identifier
25928315
Citation
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.
Results Reference
result

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

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