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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Allen A. Greiner, MD, MPH, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00594113
First received: January 3, 2008
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Colorectal Cancer
Other: Touch 2 Screen
Other: Touch screen intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Tailored Touch-Screens for Colorectal Cancer Prevention in Urban Core Clinics

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • CRC screening completion [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PAPM stage and perceived barriers among participants preferring various screening methods (iFOBT, Colonoscopy) [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Enrollment: 470
Study Start Date: August 2007
Study Completion Date: January 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Multimedia Colorectal Cancer Screening
Other: Touch 2 Screen
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
Other: Touch screen intervention
Touch screen intervention

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594113

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Allen A. Greiner, MD, MPH
Investigators
Principal Investigator: Allen A. Greiner, MD, MPH University of Kansas
  More Information

Publications:
Responsible Party: Allen A. Greiner, MD, MPH, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00594113     History of Changes
Other Study ID Numbers: 1RO1CA119098-01
Study First Received: January 3, 2008
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014