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

Not Applicable

Completed

• Conditions: Cancer of the Colon
• Interventions: Behavioral: Opt-In Outreach; Behavioral: Opt-Out Outreach

• Registration Number: NCT02929186
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-11
• Study Start: 2017-01
• Primary Completion: 2017-06-15
• Study Completion: 2017-11-15
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opt-In	Opt-In Outreach	Opt-In Outreach
Opt-Out	Opt-Out Outreach	Opt-Out Outreach

Primary Outcome Measures

Name	Time	Method
FIT Completion Rate	3 months	The percentage of participants who successfully complete the FIT.

Secondary Outcome Measures

Name	Time	Method
Mail/Electronic Message Engagement	3 months	The percentage of people who send responses using either mail or electronic messaging.