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Clinical Trials/NCT02929186
NCT02929186
Completed
Not Applicable

Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach

University of Pennsylvania0 sites314 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer of the Colon
Sponsor
University of Pennsylvania
Enrollment
314
Primary Endpoint
FIT Completion Rate
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).

Detailed Description

This is a randomized controlled pilot study aimed at testing different outreach strategies to increase colorectal cancer screening using mailed fecal immunohistochemical testing (FIT). The investigators will randomize a cohort of subjects between the ages of 50-74 into 2 arms: 1. Opt-In - subject must actively choose to receive a home FIT kit. 2. Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
November 15, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Between 50 to 74 years old
  • Has received care at the Division of Internal Medicine
  • Due for screening
  • Asymptomatic for colorectal cancer (CRC)

Exclusion Criteria

  • Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (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. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
  • Has history of colitis other than Crohn's disease or ulcerative colitis
  • Has had a colectomy
  • Has a 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 Rate

Time Frame: 3 months

The percentage of participants who successfully complete the FIT.

Secondary Outcomes

  • Mail/Electronic Message Engagement(3 months)

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