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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594113
• Other study ID #: 1RO1CA119098-01
• Status: Completed
• Phase: N/A
• First received: January 3, 2008
• Last updated: June 18, 2012
• Start date: August 2007
• Est. completion date: January 2012

Study information

• Verified date: June 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: January 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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
• Touch screen intervention
Touch screen intervention

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Allen A. Greiner, MD, MPH	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRC screening completion		90 Days	No
Secondary	PAPM stage and perceived barriers among participants preferring various screening methods (iFOBT, Colonoscopy)		90 Days	No