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

Cancer of the Colon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929186
• Other study ID #: 826047
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: May 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: November 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Colon
• Colonic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FIT Completion Rate	The percentage of participants who successfully complete the FIT.	3 months
Secondary	Mail/Electronic Message Engagement	The percentage of people who send responses using either mail or electronic messaging.	3 months