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Study of Using Computerized Education to Increase Patients' Confidence in Their Ability to Be Screened for Colon Cancer

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ClinicalTrials.gov Identifier: NCT00273585
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : September 8, 2006
Sponsor:
Information provided by:
University of California, Davis

Study Description
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Brief Summary:
The purpose of this study is to determine whether a newly developed educational software program is effective in increasing patients' confidence in their ability to undergo colon cancer screening. If the software is effective in this regard, the study will also determine if increased confidence to undergo screening leads to more people being screened and to people feeling as though their decision about screening was informed.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Screening Device: Personally-tailored educational software program Phase 3

Detailed Description:
Background: Interactive multimedia computer programs (IMCPs) show promise for facilitating informed patient decisions. However, it is unclear whether IMCPs can activate patients by delivering personally tailored information to bolster self-efficacy, a key mediator of health behavior. It is also unclear whether IMCPs might be employed to lessen disparities in care experienced by less educated people by tailoring self-efficacy enhancing information to educational level and compensating for provider biases in communication. Finally, the optimal way to deploy IMPCs in primary care (e.g. before versus following an office visit) remains unclear. Aims/Hypotheses: We will compare changes in colorectal cancer (CRC) screening self-efficacy, intention, uptake, and informed decision making resulting from an IMCP providing personally tailored information (to subject educational level and self-efficacy) intended to boost self-efficacy with changes resulting from a non-tailored control IMCP. We hypothesize both the intervention and control condition will result in increases in CRC screening self-efficacy, but increases will be significantly greater in the intervention group. We also hypothesize both the intervention and control condition will increase CRC screening intention, uptake, and informed decision making, but increases will be greater in the intervention group and will be mediated by self-efficacy enhancement. Methods: Pilot randomized controlled trial (RCT) of 2 groups, comparing a PCN office visit-linked, tailored (to subject self-efficacy) IMCP software program plus mailed reminders versus a non-tailored CRC screening IMCP software program plus mailed reminders (control). Screening methods targeted will be fecal occult blood testing, flexible sigmoidoscopy, colonoscopy, and computed tomographic virtual colonoscopy. Primary outcomes will be CRC screening self-efficacy, intention, uptake, and informed decision making. Implications: Our pilot is powered to detect a significant effect on CRC screening self-efficacy but not other outcomes; however, by conducting it as we would a future and larger RCT, we will determine protocol feasibility. If our hypotheses are confirmed, it would imply cancer screening IMCPs should be focused on enhancing self-efficacy. Since self-efficacy is a mediator of many patient and health care provider behaviors, it would also imply that similar IMCPs could be developed to support a host of patient and professional education efforts.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Software-Based Enhancement of Colorectal Cancer Screening Self-Efficacy
Study Start Date : August 2005
Study Completion Date : February 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Colorectal cancer screening self-efficacy

Secondary Outcome Measures :
  1. Colorectal cancer screening intention
  2. Colorectal cancer screening decisional conflict

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 50
  • Able to read and speak English
  • Have a telephone and permanent mailing address
  • Have adequate vision, hearing, and hand function to utilize a multimedia software program on a laptop computer
  • Lack up to date status for CRC screening

Exclusion Criteria:

  • Personal history of biopsy-proven colorectal adenoma or CRC
  • Personal history of inflammatory bowel disease involving the colon, unless limited to the rectum
  • Current symptoms worrisome for colorectal neoplasm (e.g. rectal bleeding, change in stool caliber)
  • Colorectal cancer in 1 or more first degree relatives
  • Familial adenomatous polyposis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273585


Locations
United States, California
Department of Family & Community Medicine, UC Davis School of Medicine
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Anthony F Jerant, MD Department of Family & Community Medicine, UC Davis School of Medicine
More Information
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ClinicalTrials.gov Identifier: NCT00273585     History of Changes
Other Study ID Numbers: 200412524-2
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: September 2006

Keywords provided by University of California, Davis:
Fecal occult blood testing
Flexible sigmoidoscopy
Colonoscopy
Self-efficacy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases