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Clinical Trials/NCT01575990
NCT01575990
Completed
Not Applicable

Improving Appropriate Colorectal Cancer Screening in Elderly Patients

University of North Carolina, Chapel Hill1 site in 1 country424 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Early Detection of Cancer
Sponsor
University of North Carolina, Chapel Hill
Enrollment
424
Locations
1
Primary Endpoint
Appropriate colorectal cancer screening
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this research study is to explore ways to improve appropriate colorectal cancer (CRC) screening in the elderly by attempting to target screening in those most likely to benefit and avoiding screening in those least likely to benefit.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
February 2015
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Appropriate colorectal cancer screening

Time Frame: Six months after intervention or control was adminstered

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.

Secondary Outcomes

  • Appropriate screening for health strata(Six months after intervention or control was adminstered)
  • Appropriate colorectal cancer screening decisions(At baseline (after intervention or control was administered))
  • Appropriate screening and mediators(Six months after intervention or control was adminstered)
  • Appropriate screening for stool cards(Six months after intervention or control was adminstered)

Study Sites (1)

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