Computer-Based Tailored or Standard Information for Colorectal Cancer Screening
|ClinicalTrials.gov Identifier: NCT00955188|
Recruitment Status : Completed
First Posted : August 10, 2009
Last Update Posted : December 21, 2012
RATIONALE: A computer program that provides information on colorectal cancer screening based on a patient's test preferences may be more effective than a computer program that gives standard information in helping patients get regular colorectal cancer screenings.
PURPOSE: This randomized clinical trial is studying computer-based tailored information to see how well it works compared with standard information for colorectal cancer screening.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Other: computer-assisted intervention Other: educational intervention Other: medical chart review|
- To evaluate the effectiveness of a preference-tailored (PT) intervention vs standard information (SI) delivered via computer for increasing patients' adherence to colorectal cancer (CRC)-screening guidelines in a randomized controlled trial in two racially/ethnically diverse geographic locations.
- To assess the impact of the intervention on patient perceptions of informed-decision making, physician recommendation for CRC screening, decision conflict and satisfaction, and intention to get screened 3 days after a primary care visit.
- To conduct a cost-effectiveness analysis of a preference-tailored strategy for increasing CRC screening utilization.
OUTLINE: This is a multicenter study. Patients are randomized by the computer program to 1 of 3 intervention arms.
- Arm I (preference-tailored intervention): Patients receive overview information about colorectal cancer (CRC), including graphics and descriptions of the colon and colon polyps. Patients then complete a preference-assessment exercise test by using a specially designed website. A brief description of the test is given at this time, and patients are offered the option to learn more about their preference-matched test. Patients are then given a list of other available CRC-screening tests with a brief description and option to learn more about each test. The program informs them when all information has been viewed. At the time the patients exit the program, or have viewed all the information available, they are asked to choose which test is preferable to receive from a list of existing test options.
- Arm II (standard information intervention): Patients receive overview information as in arm I. The patients then use a website listing of the four existing CRC screening test options along with graphical representations. They are allowed to interact with this web page to view basic or more information about any or all of the tests. The program informs them when all the information has been viewed. At this point, patients are asked to choose which test they would prefer to receive from a list of existing test options, as in arm I.
- Arm III (usual care): Patients receive usual care and do not receive any extra educational materials. Patients may receive a telephone follow up at 12 months.
Upon completion of the intervention, patients in arms I and II receive a printout to take with them to their upcoming appointment. For those in arm I, this printout will include their top three attributes, their preference-matched test, and their final test choice. For those in arm II, this printout will include a list of the four screening tests but will not list their final test choice.
Patients in arm I and II undergo a 3-day follow-up telephone interview. Medical charts of all patients in all 3 arms are reviewed at 12 months.
|Study Type :||Observational|
|Actual Enrollment :||345 participants|
|Official Title:||Evaluating a Preference-tailored Intervention to Increase CRC Screening in Primary Care Settings|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||May 2008|
- Adherence to colorectal cancer screening at 12 months post-intervention [ Time Frame: 12 months ]
- Elements of informed decision making [ Time Frame: 12 months ]
- Knowledge about screening options [ Time Frame: 12 months ]
- Decisional conflict and satisfaction [ Time Frame: 12 months ]
- Intention to get screened [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955188
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Sarah T. Hawley, PhD, MPH||University of Michigan Rogel Cancer Center|