Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach
1 other identifier
interventional
314
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 11, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2017
CompletedMay 26, 2020
May 1, 2020
6 months
October 7, 2016
May 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
FIT Completion Rate
The percentage of participants who successfully complete the FIT.
3 months
Secondary Outcomes (1)
Mail/Electronic Message Engagement
3 months
Study Arms (2)
Opt-In
EXPERIMENTALOpt-In Outreach
Opt-Out
EXPERIMENTALOpt-Out Outreach
Interventions
Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to elect to receive a home FIT kit or report prior screening.
Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to choose not to receive a home FIT kit or report prior screening. A FIT kit will otherwise be sent to the subject as a default.
Eligibility Criteria
You may qualify if:
- Between 50 to 74 years old
- Has received care at the Division of Internal Medicine
- Due for screening
- Asymptomatic for colorectal cancer (CRC)
You may not qualify if:
- 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
- Has history of lower GI bleeding
- Has metastatic (Stage IV) blood or solid tumor cancer
- Has end stage renal disease
- Has cirrhosis
- Has heart failure
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shivan Mehta, MD
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Chyke Doubeni, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2016
First Posted
October 11, 2016
Study Start
January 1, 2017
Primary Completion
June 15, 2017
Study Completion
November 15, 2017
Last Updated
May 26, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share