NCT00251862

Shared Decision-Making for Colorectal Cancer Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 825 (actual)
• Sponsor: Agency for Healthcare Research and Quality (AHRQ) · Federal
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this study is to conduct a three-arm randomized controlled trial to evaluate the impact of an interactive, web-based decision aid on shared decision-making and patient adherence to colorectal cancer (CRC) screening recommendations.

Detailed description

Colorectal cancer (CRC) is the second leading cause of cancer-related death and third most commonly diagnosed cancer among men and women in the United States. Screening has been shown to be a cost-effective strategy for reducing both CRC mortality through early detection and incidence through the detection and removal of precancerous adenomatous polyps (adenomas). Despite a compelling rationale and widespread endorsement by authoritative groups, screening rates remain far below those necessary to achieve significant reductions in CRC mortality or incidence. Poor patient acceptance and non-adherence to screening recommendations are partly responsible for low screening rates. Shared decision-making has been advocated as a potentially effective yet unproven strategy for addressing this problem. Implicit in this approach is the need for an unbiased decision aid that not only educates patients about the pros and cons of the different strategies so as to enable them to identify a preferred strategy but also empowers patients to take a proactive role in the decision-making process, thereby increasing satisfaction and promoting adherence. From a logistical standpoint, the decision aid must also be easy to implement in the ambulatory setting so as to maximize use but minimize demands on physician time and office resources. To address this need, we have developed an interactive, web-based decision aid and implementation strategy for use in routine clinical practice. Comparison(s): Average risk subjects assigned to one of two intervention arms (decision aid alone versus decision aid plus personalized risk assessment with feedback) compared to a control arm(generic website that discusses lifestyle changes that can reduce overall cancer risk).

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Web-based decision aid plus personalized risk assessment	Patients review a computer-based decision aid that discuss the pros and cons of of 5 recommended CRC screening options and provides personalized 10-year estimates of CRC risk prior to meeting with their provider to discuss CRC screening.
BEHAVIORAL	Web-based decision aid alone	Patients review a computer-based decision aid that discuss the pros and cons of the 5 recommended CRC screening options prior to meeting with their provider to discuss CRC screening.
BEHAVIORAL	Generic website	Patients review a generic website that discuss ways to reduce overall cancer risk.

Timeline

• Start date: 2005-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2005-11-11
• Last updated: 2013-12-27
• Results posted: 2013-12-02

Locations

2 sites across 1 country: United States