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Randomized Controlled Trial of Software-Based Enhancement of Colorectal Cancer Screening Self-Efficacy


Phase 3
50 Years
N/A
Not Enrolling
Both
Colorectal Cancer Screening

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Colorectal cancer screening self-efficacy

Principal Investigator

Anthony F Jerant, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

200412524-2

NCT ID:

NCT00273585

Start Date:

August 2005

Completion Date:

February 2006

Related Keywords:

  • Colorectal Cancer Screening
  • Fecal occult blood testing
  • Flexible sigmoidoscopy
  • Colonoscopy
  • Self-efficacy
  • Colorectal Neoplasms

Name

Location

Department of Family & Community Medicine, UC Davis School of MedicineSacramento, California  95817