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

NCT ID: NCT02929186

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-11-15

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.

Conditions

Cancer of the Colon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Opt-In

Opt-In Outreach

Group Type: EXPERIMENTAL

Opt-In Outreach

Intervention Type: BEHAVIORAL

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.

Opt-Out

Opt-Out Outreach

Group Type: EXPERIMENTAL

Opt-Out Outreach

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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
• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shivan Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Chyke Doubeni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Other Identifiers

826047

Identifier Type: -

Identifier Source: org_study_id