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Impact of Risk Stratification on Shared Decision-Making for Colorectal Cancer Screening

50 Years
75 Years
Open (Enrolling by invite only)
Colorectal Cancer

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Trial Information

Impact of Risk Stratification on Shared Decision-Making for Colorectal Cancer Screening

Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United
States. Screening by any of at least 6 different methods is a cost-effective yet
underutilized strategy for reducing both CRC incidence and mortality. Because these methods
differ with respect to risks and benefits and because existing evidence fails to identify a
single best strategy, most authoritative groups advocate a shared decision-making (SDM)
approach when selecting an appropriate screening strategy. SDM is a sequential, interactive
process involving information exchange, values clarification, decision-making and mutual
agreement. To facilitate this process, patient-oriented decision aids have been developed to
enable patients to identify a preferred strategy based on personal values and empower them
to participate in the decision-making process. Our recent studies to date find that
although decision aids enable patients to make informed choices, providers are often
unwilling to acquiesce to patient preferences when they differ from their own. Since
accurate risk assessment is a critical component of effective clinical decision-making, the
investigators postulate that risk stratification for the point prevalence of advanced
colorectal neoplasia will enable providers to incorporate objective risk-based criteria in
their decision-making when considering patient preferences for screening. To that end, the
investigators have recently developed and validated the so-called "Advanced Colorectal
Neoplasia Index [ACNI]" that stratifies patients into low versus intermediate/high risk
categories based on available clinical data, including age, sex, race/ethnicity, smoking
history, daily alcohol intake and use of non-steroidal anti-inflammatory drugs. The overall
objective of this study is to determine whether risk stratification using the ACNI
influences clinical decision-making related to screening test selection and adherence to
screening within a SDM framework.

Hypothesis: Providers who incorporate risk estimates of ACN in their decision-making when
recommending screening tests are more likely to consider patient preferences for options
other than colonoscopy than providers lacking this information.

Inclusion Criteria:

- English-speaking "average-risk" patients 50 to 75 years of age;

- Due for CRC screening based on current recommendations (i.e. no prior screening or >
1year since last fecal occult blood testing [FOBT], > 3 years since last stool DNA
test, > 5 years since last flexible sigmoidoscopy, virtual colonoscopy or
double-contrast barium enema [DCBE], or > 10 years since last colonoscopy);

- Under the direct care of a staff (attending) primary care provider or physician

- without major co-morbidities that preclude CRC screening.

Exclusion Criteria:

- High-risk condition (personal history of colorectal cancer or polyps, family history
of colorectal cancer or polyps involving one or more first degree relatives < 60
years of age, chronic inflammatory bowel disease);

- Presence of "alarm" gastrointestinal symptoms, including rectal bleeding, recent
change in bowel habits, abdominal pain, unexplained weight loss and iron deficiency

- Comorbidities that preclude CRC screening by any method;

- 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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Screening test ordered

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Paul C Schroy III, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2012

Completion Date:

March 2014

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer screening
  • Shared decision-making
  • Patient preferences
  • Risk assessment
  • Advanced colorectal neoplasia
  • Colorectal Neoplasms



Boston Medical CenterBoston, Massachusetts  02118