Clinical trial NCT00594113: "Touch 2 Screen" Multi-media Colorectal Cancer Screening Intervention
Official title: Tailored Touch-Screens for Colorectal Cancer Prevention in Urban Core Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-01-15
Enrollment: 470
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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 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.

Primary outcomes:
measure: CRC screening completion
timeFrame: 90 Days
Secondary outcomes:
measure: PAPM stage and perceived barriers among participants preferring various screening methods (iFOBT, Colonoscopy)
timeFrame: 90 Days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Allen A. Greiner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.