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Clinical Trials/NCT03072095
NCT03072095
Completed
Not Applicable

Patient-Centered Outreach to Increase Colorectal Cancer Screening in a Community Health Setting

University of Pennsylvania1 site in 1 country281 target enrollmentApril 17, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer of the Colon
Sponsor
University of Pennsylvania
Enrollment
281
Locations
1
Primary Endpoint
FIT completion within 3 months
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This randomized controlled pilot study at the Health Annex, Family Practice & Counseling Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the feasibility of a mailed FIT approach to CRC screening in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

Detailed Description

This is a single-center RCT at the Family Practice \& Counseling Network (FPCN), a community clinic in Southwest Philadelphia with 320 eligible subjects between the ages of 50-74 randomized to two study arms: 1. text messaging outreach (text) 2. text messaging outreach with lottery for 1/5 chance to win a financial incentive (text + lottery). Findings will provide data on the feasibility of this mailed FIT approach in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

Registry
clinicaltrials.gov
Start Date
April 17, 2017
End Date
November 3, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shivan J Mehta

Principal Investigator

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

  • Between 50 and 74 years old
  • Has active medical insurance
  • Has had had at least one visit at Health Annex in the prior 12 months (at time of chart review)
  • Due for CRC screening (no colonoscopy in last 10 years, sigmoidoscopy in last 5 years, or stool testing in last 1 year)
  • Asymptomatic for CRC

Exclusion Criteria

  • Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and FOBT/FIT within twelve months of the chart review (we will exclude patients who self-report undergoing any of the above procedures)
  • Has a history of CRC
  • Has a history of other GI cancer
  • Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohns disease, ulcerative colitis)
  • Has a history of colon polyps
  • Has had a colectomy
  • Has a first-degree relative that has been diagnosed with CRC
  • Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
  • Has been diagnosed with Familial Adenomatous Polyposis (FAP).
  • Has iron deficiency anemia

Outcomes

Primary Outcomes

FIT completion within 3 months

Time Frame: 3 months

The percentage of participants who successfully complete the FIT

Secondary Outcomes

  • Response to text-based CRC screening outreach(3 months)

Study Sites (1)

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