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Clinical Trials/NCT02272244
NCT02272244
Completed
Not Applicable

Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients

Thomas Jefferson University3 sites in 1 country400 target enrollmentOctober 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Thomas Jefferson University
Enrollment
400
Locations
3
Primary Endpoint
Overall Screening Adherence
Status
Completed
Last Updated
12 months ago

Overview

Brief Summary

This study is designed to test a standard mailed intervention (SI) versus a novel decision support and navigation intervention (DSNI). Working with patients and stakeholders, this randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age, patients in community based primary care practices, and are eligible for CRC screening. We will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact on overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and knowledge and perceptions.

Registry
clinicaltrials.gov
Start Date
October 1, 2014
End Date
March 31, 2017
Last Updated
12 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or Female
  • Self-identifies as being Hispanic or Latino
  • 50 to 75 years of age

Exclusion Criteria

  • Previous diagnosis of CRC
  • Up to date with CRC screening guidelines.
  • Personal history of inflammatory bowel disease
  • Personal history of polyps
  • Family history of CRC diagnosed before the age of 60 years

Outcomes

Primary Outcomes

Overall Screening Adherence

Time Frame: 12 months

The two study groups will be compared in terms of the fraction of participants who undergo CRC screening (through SBT, colonoscopy, flexible sigmoidoscopy, etc.) within 12 months of the randomization date. Screening will be measured using data from the 6-month survey and the 12-month chart audit.

Secondary Outcomes

  • Change in Screening Decision Stage(6 months)
  • Screening Knowledge and Perceptions(6 months)
  • Test Specific Screening Adherence(12 Months)

Study Sites (3)

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