Shared Decision-Making for Colorectal Cancer Screening

Study Overview
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Brief Summary
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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
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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).

Official Title
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Shared Decision-Making for Colorectal Cancer Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Web-based decision aid plus personalized risk assessment
* Behavioral: Web-based decision aid alone
* Behavioral: Generic website


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision aid plus YourDiseaseRisk<br>Patients viewed the decision aid and completed the Your Disease Risk risk assessment tool prior to visit with their primary care provider. | Behavioral: Web-based decision aid plus personalized risk assessment<br>* 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.<br>* Other names: Decision aid, personalized risk assessment tool;|
| Experimental: Decision aid alone<br>Patient's viewed decision aid only prior to a visit with their primary care provider. | Behavioral: Web-based decision aid alone<br>* 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.<br>* Other names: Decision aid;|
| Sham Comparator: III<br>Standard care | Behavioral: Generic website<br>* Patients review a generic website that discuss ways to reduce overall cancer risk.<br>* Other names: Control condtion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Adherence (Test Completion) | Completion of a screening test within 12 months of the study visit. | 12 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Knowledge | 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. | Immediate post-intervention study visit | 
| Patient Satisfaction With Decision Making Process | 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. | Immediate post-intervention primary care provider (PCP) visit | 
| Screening Intentions | 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. | Immediate post-intervention study visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer screening, Shared decision-making, Decision aid