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Improving Appropriate Colorectal Cancer Screening in Elderly Patients


N/A
70 Years
84 Years
Open (Enrolling by invite only)
Both
Early Detection of Cancer, Colon Cancer, Decision Making, Patient-Centered Care

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Trial Information

Improving Appropriate Colorectal Cancer Screening in Elderly Patients


The investigators propose a randomized controlled trial at the patient level to determine
the efficacy of a colorectal cancer screening decision support intervention for patients
ages 70 to 84 within a clinical setting. The investigators hypothesize that the use of the
intervention will prepare patients for individualized decision making with their providers
and result in an improvement in appropriate CRC screening decisions and screening outcomes.
To assess appropriate CRC screening decisions and screening, the investigators will use a
classification scheme derived from the literature based on age and the Charlson Comorbidity
Index. Using this scheme, appropriate screening will include screening for those in the best
health because they are likely to benefit, no screening for those in the worst health
because they are unlikely to benefit, and evidence of a discussion about CRC screening for
those in the intermediate health group because the benefit is unclear.


Inclusion Criteria:



- Men and women ages 70 to 84

- Not up to date with colon cancer screening or surveillance

Exclusion Criteria:

- Men and women younger than 70 years of age or older than 84

- History of Colorectal Cancer

- Inflammatory bowel disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Appropriate colorectal cancer screening

Outcome Description:

The proportion of participants classified as having appropriate colorectal cancer screening in the intervention group compared to the control group. Appropriate screening is a combined outcome measure using patient report of completion or non-completion of CRC screening tests and patient report of discussions about CRC screening with their provider at the index visit. The outcome will be measured six months after the index visit. The index visit is the patient/provider visit that occurred after the decision support intervention or control condition was administered.

Outcome Time Frame:

Six months after intervention or control was adminstered

Safety Issue:

No

Principal Investigator

Carmen L Lewis, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina

Authority:

United States: Institutional Review Board

Study ID:

11-1638

NCT ID:

NCT01575990

Start Date:

March 2012

Completion Date:

September 2014

Related Keywords:

  • Early Detection of Cancer
  • Colon Cancer
  • Decision Making
  • Patient-Centered Care
  • Colon cancer screening
  • Decision support interventions
  • Health status
  • Patient-centered care
  • Age
  • Randomized controlled trial
  • Double blind
  • UNC
  • Colonic Neoplasms

Name

Location
Duke Practiced Based Research Network Durham, North Carolina  27710