Shared Decision-Making for Colorectal Cancer Screening
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|ClinicalTrials.gov Identifier: NCT00251862|
Recruitment Status : Completed
First Posted : November 11, 2005
Results First Posted : December 2, 2013
Last Update Posted : December 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Behavioral: Web-based decision aid plus personalized risk assessment Behavioral: Web-based decision aid alone Behavioral: Generic website||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||825 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Shared Decision-Making for Colorectal Cancer Screening|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: Decision aid plus YourDiseaseRisk
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
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.
Other Name: Decision aid, personalized risk assessment tool
Experimental: Decision aid alone
Patient's viewed decision aid only prior to a visit with their primary care provider.
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.
Other Name: Decision aid
Sham Comparator: III
Behavioral: Generic website
Patients review a generic website that discuss ways to reduce overall cancer risk.
Other Name: Control condtion
- Patient Adherence (Test Completion) [ Time Frame: 12 months post-intervention ]Completion of a screening test within 12 months of the study visit.
- Patient Knowledge [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251862
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|South Boston Community Health Center|
|Boston, Massachusetts, United States, 02127|
|Principal Investigator:||Paul C. Schroy III, MD, MPH||Boston Medical Center|