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

University of Pennsylvania

Status: Completed

Conditions: Cancer of the Colon

Treatments: Behavioral: Opt-In Outreach; Behavioral: Opt-Out Outreach

Study type: Interventional

Funder types: Other

Identifiers

NCT02929186

826047

Details and patient eligibility

About

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).

Full 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.

Enrollment: 314 patients

Sex: All

Ages: 50 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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314 participants in 2 patient groups

Opt-In

Experimental group

Description:

Opt-In Outreach

Treatment:

Behavioral: Opt-In Outreach

Opt-Out

Experimental group

Description:

Opt-Out Outreach

Treatment:

Behavioral: Opt-Out Outreach