Shared Decision-Making for Colorectal Cancer Screening

Not Applicable

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00251862
• Lead Sponsor: Agency for Healthcare Research and Quality (AHRQ)

Brief 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).

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-11-09
• Study First Submitted QC: 2005-11-09
• Study First Posted: 2005-11-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2013-07-23
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-30
• Results First Posted: 2013-12-02
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 825

Inclusion Criteria

• Asymptomatic average-risk subjects
• Under the direct care of one of participating site's staff (attending) physicians or physician extenders;
• No prior screening other than fecal occult blood testing (FOBT);
• No major co-morbidities that preclude CRC screening by any method

Exclusion Criteria

• Prior CRC screening by any method other than FOBT occult blood testing
• High-risk condition (personal history of colorectal cancer or polyps, family history of colorectal cancer or polyps involving one or more first degree relatives, chronic inflammatory bowel disease)
• Lack of fluency in written and spoken English (since decision aid and personalized risk assessment tool will be in English only due to funding issues);
• Comorbidities that preclude CRC screening by any method

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Adherence (Test Completion)	12 months post-intervention	Completion of a screening test within 12 months of the study visit.

Secondary Outcome Measures

Name	Time	Method
Patient Knowledge	Immediate post-intervention study visit	Knowledge was assessed at baseline (pretest) and at the time of the exit survey (posttest) based on responses to a 12-item questionnaire (True/False/Don't know) that inquired about CRC risk factors, the rationale and goals of screening, and age at which screening should begin. Cumulative knowledge scores (range, 0-12) were derived by summing correct responses to the 12 individual knowledge questions.
Patient Satisfaction With Decision Making Process	Immediate post-intervention primary care provider (PCP) visit	Patient satisfaction with the decision-making process (SDMP) was assessed using the validated 12-item Satisfaction with the Decision-Making Process scale. Five ordered response categories were used for each item. Each response was assigned a point score ranging from 1 for "strongly disagree" (or "poor") to 5 for "strongly agree" (or "excellent"). A cumulative score was calculated based on the summed response scores for each item (maximum score = 60). Mean item substitution was used to impute missing data.
Screening Intentions	Immediate post-intervention study visit	Screening intentions were also assessed as part of the posttest. Subjects were asked how sure they were that they would schedule an appointment to get screened for colorectal cancer and how sure they were that they would complete the screening test they scheduled. An ordered 5-point response frame was used ranging from 1 for "not at all sure" to 5 for "completely sure".

Trial Locations

Locations (2)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

South Boston Community Health Center; 🇺🇸 Boston, Massachusetts, United States