Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273585
Status:
COMPLETED
Last Update Posted:
2006-09-08
First Post:
2006-01-06
Brief Title:
Study of Using Computerized Education to Increase Patients Confidence in Their Ability to Be Screened for Colon Cancer
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Randomized Controlled Trial of Software-Based Enhancement of Colorectal Cancer Screening Self-Efficacy
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg before versus following an office visit remains unclear AimsHypotheses 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None