Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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Opt-In - subject must actively choose to receive a home FIT kit.
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Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Opt-In Opt-In Outreach |
Behavioral: Opt-In Outreach
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.
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| Experimental: Opt-Out Opt-Out Outreach |
Behavioral: Opt-Out Outreach
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.
|
Outcome Measures
Primary Outcome Measures
- FIT Completion Rate [3 months]
The percentage of participants who successfully complete the FIT.
Secondary Outcome Measures
- Mail/Electronic Message Engagement [3 months]
The percentage of people who send responses using either mail or electronic messaging.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Between 50 to 74 years old
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Has received care at the Division of Internal Medicine
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Due for screening
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Asymptomatic for colorectal cancer (CRC)
Exclusion Criteria:
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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)
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Has a history of CRC
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Has a history of other GI cancer
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Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
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Has history of colitis other than Crohn's disease or ulcerative colitis
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Has had a colectomy
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Has a relative that has been diagnosed with CRC
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Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
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Has been diagnosed with Familial Adenomatous Polyposis (FAP)
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Has iron deficiency anemia
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Has history of lower GI bleeding
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Has metastatic (Stage IV) blood or solid tumor cancer
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Has end stage renal disease
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Has cirrhosis
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Has heart failure
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Has dementia
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Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Pennsylvania
Investigators
- Principal Investigator: Shivan Mehta, MD, University of Pennsylvania
- Principal Investigator: Chyke Doubeni, MD, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 826047