- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00594113
"Touch 2 Screen" Multi-media Colorectal Cancer Screening Intervention
Tailored Touch-Screens for Colorectal Cancer Prevention in Urban Core Clinics
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Allen A. Greiner, MD, MPH, University of Kansas Medical Center
Publications and helpful links
General Publications
- Greiner KA, Geana MV, Epp A, Watson A, Filippi M, Daley CM, Engelman KK, James AS, Campbell M. A computerized intervention to promote colorectal cancer screening for underserved populations: theoretical background and algorithm development. Technol Health Care. 2012;20(1):25-35. doi: 10.3233/THC-2011-0653.
- Greiner KA, Daley CM, Epp A, James A, Yeh HW, Geana M, Born W, Engelman KK, Shellhorn J, Hester CM, LeMaster J, Buckles DC, Ellerbeck EF. Implementation intentions and colorectal screening: a randomized trial in safety-net clinics. Am J Prev Med. 2014 Dec;47(6):703-14. doi: 10.1016/j.amepre.2014.08.005. Epub 2014 Nov 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1RO1CA119098-01
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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