Choice Architecture and Colorectal Cancer Screening Outreach

Not Applicable

Completed

• Conditions: Cancer of Colon
• Interventions: Behavioral: Colonoscopy outreach + mailed FIT follow-up; Behavioral: Colonoscopy only; Behavioral: Colonoscopy + Mailed FIT outreach and follow-up

• Registration Number: NCT03246438
• Lead Sponsor: University of Pennsylvania

Brief Summary

This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy outreach only, in patients between 50-74 years old, who have received care at the University City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control), Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test) (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).

Detailed Description

This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The investigators will randomize participants to one of three study arms:

Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Study Start: 2017-11-14
• Primary Completion: 2018-03-14
• Study Completion: 2018-07-14
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 423

Inclusion Criteria

• Between 50 and 74 years old
• Has a primary care provider who is a University City or Valley Forge Family Medicine provider
• Has had at least 2 office visits at either practice
• Is due for colorectal cancer screening
• Is asymptomatic for CRC
• Subject's zip code is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area

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Exclusion Criteria

• Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, or FOBT/FIT within twelve months of chart review (we will exclude patients who self-report any of the above procedures)
• Has a history of CRC or colonic polyps
• Has a history of GI cancer
• Has a history of confirmed Inflammatory Bowel Disease (IBD)
• has a history of colitis other than Crohns disease or ulcerative colitis)
• Has a first degree relative that has been diagnosed with CRC
• Has had a colectomy
• Has been diagnosed with Familial Adenomatous Polyposis (FAP)
• Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
• Has iron-deficiency anemia
• Has a 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential Choice	Colonoscopy outreach + mailed FIT follow-up	Colonoscopy outreach + mailed FIT follow-up
Control	Colonoscopy only	Colonoscopy only outreach and follow-up
Active Choice	Colonoscopy + Mailed FIT outreach and follow-up	Colonoscopy + mailed FIT outreach and follow-up

Primary Outcome Measures

Name	Time	Method
CRC screening completion	4 months	The percentage of participants who successfully complete FIT or colonoscopy

Secondary Outcome Measures

Name	Time	Method
Choice of screening test	4 months	The percentage of participants who choose either screening method (FIT vs. colonoscopy)

Trial Locations

Locations (1)

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States