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

Primary Purpose

Colorectal Cancer Screening

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Personally-tailored educational software program
Sponsored by
University of California, Davis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer Screening focused on measuring Fecal occult blood testing, Flexible sigmoidoscopy, Colonoscopy, Self-efficacy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Family & Community Medicine, UC Davis School of Medicine

Outcomes

Primary Outcome Measures

Colorectal cancer screening self-efficacy

Secondary Outcome Measures

Colorectal cancer screening intention
Colorectal cancer screening decisional conflict

Full Information

First Posted
January 6, 2006
Last Updated
September 6, 2006
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00273585
Brief Title
Study of Using Computerized Education to Increase Patients' Confidence in Their Ability to Be Screened for Colon Cancer
Official Title
Randomized Controlled Trial of Software-Based Enhancement of Colorectal Cancer Screening Self-Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Davis

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
Fecal occult blood testing, Flexible sigmoidoscopy, Colonoscopy, Self-efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Personally-tailored educational software program
Primary Outcome Measure Information:
Title
Colorectal cancer screening self-efficacy
Secondary Outcome Measure Information:
Title
Colorectal cancer screening intention
Title
Colorectal cancer screening decisional conflict

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony F Jerant, MD
Organizational Affiliation
Department of Family & Community Medicine, UC Davis School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Family & Community Medicine, UC Davis School of Medicine
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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