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Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colonoscopy Only
Choice
FIT Only
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring screening, prevention, colonoscopy, stool testing

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. At least 1 visit with CHDC in the past 2 years
  2. Not up to date on CRC screening (no evidence of colonoscopy in the last 10 years, sigmoidoscopy in the last 5 years, or stool testing in the past 12 months)

Exclusion Criteria:

  1. History of CRC or polyps
  2. Significant family history of CRC
  3. History of Inflammatory Bowel Disease or Ulcerative Colitis
  4. History of colectomy
  5. History of metastatic cancer
  6. Current use of Medication Assisted Therapy (MAT)

Sites / Locations

  • Community Health and Dental Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Colonoscopy Only

Choice

FIT Only

Arm Description

Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in colonoscopy, and including a referral for the procedure at a local endoscopy center. Participants will be provided a phone number if interested in navigated colonoscopy scheduling.

Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in their choice of either colonoscopy or mailed fecal immunochemical testing (FIT). The letter will include both a referral for the colonoscopy at a local endoscopy enter and a FIT kit with a lab requisition and instructions for completion.

Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in FIT testing. The letter will include a FIT kit with lab requisition and instructions for completion.

Outcomes

Primary Outcome Measures

Colorectal Cancer Screening Completion
Screening completion rate in arm 2 (Choice) to arm 1 (Colonoscopy only) and arm 3 (FIT only) separately.

Secondary Outcome Measures

Choice of Colorectal Cancer Screening Test
The proportion of patients choosing either FIT or Colonoscopy in study arm 2 (Choice)

Full Information

First Posted
January 12, 2021
Last Updated
January 12, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Comprehensive Cancer Network
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1. Study Identification

Unique Protocol Identification Number
NCT04711473
Brief Title
Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting
Official Title
Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2021 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
November 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Comprehensive Cancer Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 3-arm randomized trial aimed at increasing rates of participation in colorectal cancer (CRC) screening by outreach to patients' homes using choice architecture informed by behavioral science principles.
Detailed Description
The investigators will evaluate the effectiveness of mailed outreach with choice between colonoscopy and FIT, and FIT alone, as compared to colonoscopy alone in increasing CRC screening rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
screening, prevention, colonoscopy, stool testing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colonoscopy Only
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in colonoscopy, and including a referral for the procedure at a local endoscopy center. Participants will be provided a phone number if interested in navigated colonoscopy scheduling.
Arm Title
Choice
Arm Type
Experimental
Arm Description
Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in their choice of either colonoscopy or mailed fecal immunochemical testing (FIT). The letter will include both a referral for the colonoscopy at a local endoscopy enter and a FIT kit with a lab requisition and instructions for completion.
Arm Title
FIT Only
Arm Type
Experimental
Arm Description
Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in FIT testing. The letter will include a FIT kit with lab requisition and instructions for completion.
Intervention Type
Behavioral
Intervention Name(s)
Colonoscopy Only
Intervention Description
Mailed letter asking participants to complete CRC screening by colonoscopy
Intervention Type
Behavioral
Intervention Name(s)
Choice
Intervention Description
Mailed letter and FIT test asking participants to complete CRC screening by their choice of either colonoscopy or mailed FIT
Intervention Type
Behavioral
Intervention Name(s)
FIT Only
Intervention Description
Mailed letter and FIT test asking participants to complete CRC screening by mailed FIT
Primary Outcome Measure Information:
Title
Colorectal Cancer Screening Completion
Description
Screening completion rate in arm 2 (Choice) to arm 1 (Colonoscopy only) and arm 3 (FIT only) separately.
Time Frame
6 months from initial outreach
Secondary Outcome Measure Information:
Title
Choice of Colorectal Cancer Screening Test
Description
The proportion of patients choosing either FIT or Colonoscopy in study arm 2 (Choice)
Time Frame
6 months from initial outreach

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 1 visit with CHDC in the past 2 years Not up to date on CRC screening (no evidence of colonoscopy in the last 10 years, sigmoidoscopy in the last 5 years, or stool testing in the past 12 months) Exclusion Criteria: History of CRC or polyps Significant family history of CRC History of Inflammatory Bowel Disease or Ulcerative Colitis History of colectomy History of metastatic cancer Current use of Medication Assisted Therapy (MAT)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health and Dental Care
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19465
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting

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