Colorectal Cancer Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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