Randomized Controlled Trial of Software-Based Enhancement of Colorectal Cancer Screening Self-Efficacy
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Colorectal cancer screening self-efficacy
Anthony F Jerant, MD
Principal Investigator
Department of Family & Community Medicine, UC Davis School of Medicine
United States: Food and Drug Administration
200412524-2
NCT00273585
August 2005
February 2006
Name | Location |
---|---|
Department of Family & Community Medicine, UC Davis School of Medicine | Sacramento, California 95817 |