Choice Architecture and Colorectal Cancer Screening Outreach

February 19, 2019 updated by: University of Pennsylvania

Choice Architecture and Mailed Outreach for Colorectal Cancer Screening

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

423

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
Colonoscopy only outreach and follow-up
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.
Other Names:
  • Control
Experimental: Sequential Choice
Colonoscopy outreach + mailed FIT follow-up
Behavioral: 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.
Other Names:
  • Sequential Choice
Experimental: Active Choice
Colonoscopy + mailed FIT outreach and follow-up
Behavioral: 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.
Other Names:
  • Active Choice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRC screening completion
Time Frame: 4 months
The percentage of participants who successfully complete FIT or colonoscopy
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choice of screening test
Time Frame: 4 months
The percentage of participants who choose either screening method (FIT vs. colonoscopy)
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Chyke Doubeni, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2017

Primary Completion (Actual)

March 14, 2018

Study Completion (Actual)

July 14, 2018

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 827818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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