Shared Decision-Making for Colorectal Cancer Screening
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Behavioral: Decision aid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention |
| Official Title: | Shared Decision-Making for Colorectal Cancer Screening |
- Patient adherence
- Patient satisfaction
- Patient knowledge
| Estimated Enrollment: | 900 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | September 2005 |
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).
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 FOBT;
- No major co-morbidities that preclude CRC screening by any method
Exclusion Criteria:
- Prior CRC screening by any method other than fecal 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
Contacts and Locations| Contact: Julie Glick, BA, MPH | 617-638-8348 | julie.glick@bmc.org |
| Contact: Patricia Robinson, MEd | 617- 414-7893 | patricia.robinson@bmc.org |
| United States, Massachusetts | |
| Boston Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Julie Glick, BA, MPH 617-638-8348 julie.glick@bmc.org | |
| South Boston Community Health Center | Recruiting |
| Boston, Massachusetts, United States, 02127 | |
| Contact: Patricia Robinson, MEd 617-414-7893 patricia.robinson@bmc.org | |
| Principal Investigator: | Paul C. Schroy III, MD, MPH | Boston Medical Center |
More Information
No publications provided by Agency for Healthcare Research and Quality (AHRQ)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00251862 History of Changes |
| Other Study ID Numbers: | 5 R01 HS013912-03, 5 R01 HS013912-03 |
| Study First Received: | November 9, 2005 |
| Last Updated: | November 9, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
|
Colorectal cancer screening Shared decision-making Decision aid |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013