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Shared Decision-Making for Colorectal Cancer Screening

50 Years
75 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Shared Decision-Making for Colorectal Cancer Screening

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Outcome Measure:

Patient adherence

Principal Investigator

Paul C. Schroy III, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center


United States: Federal Government

Study ID:

5 R01 HS013912-03



Start Date:

January 2005

Completion Date:

September 2005

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer screening
  • Shared decision-making
  • Decision aid
  • Colorectal Neoplasms



Boston Medical Center Boston, Massachusetts  02118
South Boston Community Health Center Boston, Massachusetts  02127