"Touch 2 Screen" Multi-media Colorectal Cancer Screening Intervention

June 18, 2012 updated by: Allen A. Greiner, MD, MPH

Tailored Touch-Screens for Colorectal Cancer Prevention in Urban Core Clinics

The primary purpose of this study is to determine the effectiveness of a multi-media presentation and survey to increase screening for colorectal cancer. Content of this presentation is based on the concept of "implementation intentions," an advanced planning model taken from the Theory of Planned Behavior. The multi-media presentation is delivered in a touch-screen computer format and contains messages about colorectal cancer that are tailored to each participant based on individual survey responses. It is hypothesized that tailored messages and defining implementation intentions may have a relationship with completion of colorectal cancer screening.

Study Overview

Status

Completed

Conditions

Detailed Description

The majority of the intervention will be delivered in primary care settings on low-cost touch-screen computers through multi-media audio-narrative and video messages. Studies have not tested the effectiveness of tailored communications specified to stated "implementation intentions" for improving CRC screening. A randomized design will test a comparison of generic information versus a multi-media tailored intervention that specifically addresses each participant's screening test preference, current CRC screening decisional state (Precaution Adoption Process Model), and specified to stated "implementation intentions" (the "when," "Where," and "how" details of screening.) Behavioral intervention materials in English and Spanish will be developed with the help of cultural experts, pilot tests, and interviews that will test salience and cultural appropriateness of audio, video, and graphic messages for low-income minorities and whites. The study will be conducted with 460 patients eligible for CRC screening and recruited while presenting for care in urban clinics. All participants will receive baseline touch-screen administered assessment and, depending on stated preference, be offered either immunochemical fecal occult blood test (iFOBT-InSureTM) or a colonoscopy. Participants will be randomized to either "C" (comparison group-computer delivered generic CRC information) or "TI2" (active intervention-computer delivered tailored messaging based on individual PAPM stage, behavioral constructs, and "implementation intentions"). A brief office exit survey will assess patient-provider discussions of CRC screening and satisfaction with computerized message materials. A 90-day post randomization follow-up telephone call assessment with all participants will reassess PAPM stage and perceived CRC screening barriers.

The primary outcome will be CRC screening completion at 90 days. Secondary outcomes will assess 90-day PAPM stage and perceived barriers among participants preferring various screening methods (iFOBT, Colonoscopy). This intervention will provide information on the utility of embedding a low-cost technologically advanced "implementation intentions" based behavioral intervention in primary care practice.

Study Type

Interventional

Enrollment (Actual)

470

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must be at least 50 years of age
  • Must not have had a colonoscopy in the last 10 years
  • Must not have completed Fecal Occult Blood Test in the past year
  • Must not have a family history of colorectal cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Multimedia Colorectal Cancer Screening
Multi-media presentation and survey to increase screening for colorectal cancer. Content of this presentation is based on the concept of "implementation intentions," an advanced planning model taken from the Theory of Planned Behavior
Touch screen intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CRC screening completion
Time Frame: 90 Days
90 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
PAPM stage and perceived barriers among participants preferring various screening methods (iFOBT, Colonoscopy)
Time Frame: 90 Days
90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Allen A. Greiner, MD, MPH, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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