Shared Decision-Making for Colorectal Cancer Screening

Agency for Healthcare Research and Quality (AHRQ)

Status: Completed

Conditions: Colorectal Cancer

Treatments: Behavioral: Web-based decision aid alone; Behavioral: Generic website; Behavioral: Web-based decision aid plus personalized risk assessment

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00251862

5R01HS013912-05

Details and patient eligibility

About

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.

Full 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).

Enrollment: 825 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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825 participants in 3 patient groups

Decision aid plus YourDiseaseRisk

Experimental group

Description:

Patients viewed the decision aid and completed the Your Disease Risk risk assessment tool prior to visit with their primary care provider.

Treatment:

Behavioral: Web-based decision aid plus personalized risk assessment

Decision aid alone

Experimental group

Description:

Patient's viewed decision aid only prior to a visit with their primary care provider.

Treatment:

Behavioral: Web-based decision aid alone

III

Sham Comparator group

Description:

Standard care

Treatment:

Behavioral: Generic website