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

Study Overview
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Brief Summary
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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
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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: Opt-In - subject must actively choose to receive a home FIT kit. Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.

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

Conditions
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Cancer of the Colon

Intervention / Treatment
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* Behavioral: Opt-In Outreach
* Behavioral: Opt-Out Outreach


Participation Criteria
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Eligibility Criteria
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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 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 Has dementia Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opt-In<br>Opt-In Outreach | Behavioral: Opt-In Outreach<br>* 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.<br>|
| Experimental: Opt-Out<br>Opt-Out Outreach | Behavioral: Opt-Out Outreach<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIT Completion Rate | The percentage of participants who successfully complete the FIT. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mail/Electronic Message Engagement | The percentage of people who send responses using either mail or electronic messaging. | 3 months |