Choice Architecture and Colorectal Cancer Screening Outreach

Cancer of Colon Clinical Trial

Official title:

Choice Architecture and Mailed Outreach for Colorectal Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246438
• Other study ID #: 827818
• Status: Completed
• Phase: N/A
• Start date: November 14, 2017
• Est. completion date: July 14, 2018

Study information

• Verified date: February 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: July 14, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Cancer of Colon
• Colonic Neoplasms
• Colorectal Neoplasms

Intervention

Behavioral:
• Colonoscopy only
Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy.
• Colonoscopy outreach + mailed FIT follow-up
Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit.
• Colonoscopy + Mailed FIT outreach and follow-up
Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line OR complete the enclosed mailed FIT kit. Subjects who have not completed FIT or scheduled colonoscopy within 4 weeks will be receive a reminder letter to either schedule colonoscopy or complete the mailed FIT kit previously sent.

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRC screening completion	The percentage of participants who successfully complete FIT or colonoscopy	4 months
Secondary	Choice of screening test	The percentage of participants who choose either screening method (FIT vs. colonoscopy)	4 months