Mailed FIT Outreach 2022

Pragmatic Trial of Behavioral Interventions to Increase Response to Mailed FIT Outreach

This project aims to evaluate different approaches to increase colorectal cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, we will evaluate different approaches to increase response rate to mailed fecal immunochemical test (FIT) kits among eligible patients, including differentiated packaging, sending text reminders, and personalized reminders.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colon Cancer
• Intervention / Treatment: Behavioral: Differentiated Box; Behavioral: Text; Behavioral: Reminder; Behavioral: No Reminder; Behavioral: No Text; Behavioral: Standard Mail

Detailed Description

While colonoscopy procedures are recommended by guidelines for early detection of colorectal cancer, colonoscopy access remains limited due to delays in screening due to the pandemic and capacity issues. In this project, we will evaluate different ways of reaching out to eligible patients to encourage them to participate in colorectal cancer screening using fecal immunochemical testing (FIT). In a mailed FIT outreach campaign, we will compare user friendly packaging, text messaging, and personalized reminders to standard outreach with the goal of increasing colorectal cancer screening uptake.

• Study Type: Interventional
• Enrollment (Actual): 5460
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients ages 50-74 with Penn as preferred lab
2. Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
3. Not up to date on colorectal cancer screening per Health Maintenance (no colonoscopy in the last 10 years, stool testing in the last year, flexible sigmoidoscopy in the last 5 years, FIT-DNA in the last 3 years).

Exclusion Criteria:

1. Personal or significant family history of CRC, colonic polyps, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis syndrome, other gastrointestinal cancer, gastrointestinal bleeding, iron-deficiency anemia, or inflammatory bowel disease
2. History of total colectomy, dementia or metastatic cancer
3. Currently on hospice or receiving palliative care
4. Uninsured or self-pay patients
5. Currently scheduled for a colonoscopy or sigmoidoscopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Box + Text + Reminder; Box + Text + Reminder	Behavioral: Differentiated Box; Patients will receive mailed FIT kits in a box with differentiated packaging; Behavioral: Text; Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.; Behavioral: Reminder; Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
Experimental: Arm 2: Box + Text + No Reminder; Box + Text + No Reminder	Behavioral: Differentiated Box; Patients will receive mailed FIT kits in a box with differentiated packaging; Behavioral: Text; Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.; Behavioral: No Reminder; Patients will not receive any mailed letter reminder to complete their FIT kit.
Experimental: Arm 3: Box + No Text + Reminder; Box + No Text + Reminder	Behavioral: Differentiated Box; Patients will receive mailed FIT kits in a box with differentiated packaging; Behavioral: Reminder; Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.; Behavioral: No Text; Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
Experimental: Arm 4: Box + No Text + No Reminder; Box + No Text + No Reminder	Behavioral: Differentiated Box; Patients will receive mailed FIT kits in a box with differentiated packaging; Behavioral: No Reminder; Patients will not receive any mailed letter reminder to complete their FIT kit.; Behavioral: No Text; Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
Experimental: Arm 5: Standard Mail + Text + Reminder; Standard Mail + Text + Reminder	Behavioral: Text; Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.; Behavioral: Reminder; Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.; Behavioral: Standard Mail; Patients will receive mailed FIT in a standard mailing envelope
Experimental: Arm 6: Standard Mail + Text + No Reminder; Standard Mail + Text + No Reminder	Behavioral: Text; Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.; Behavioral: No Reminder; Patients will not receive any mailed letter reminder to complete their FIT kit.; Behavioral: Standard Mail; Patients will receive mailed FIT in a standard mailing envelope
Experimental: Arm 7: Standard Mail + No Text + Reminder	Behavioral: Reminder; Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.; Behavioral: No Text; Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.; Behavioral: Standard Mail; Patients will receive mailed FIT in a standard mailing envelope
Experimental: Arm 8: Standard Mail + No Text + No Reminder; Standard Mail + No Text + No Reminder	Behavioral: No Reminder; Patients will not receive any mailed letter reminder to complete their FIT kit.; Behavioral: No Text; Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.; Behavioral: Standard Mail; Patients will receive mailed FIT in a standard mailing envelope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FIT Completion	Percent of patients who complete FIT	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FIT Completion	Percent of patients who complete FIT	6 months
FIT Positive Follow-up Scheduling	Percent of patients with FIT+ results that schedule a colonoscopy	6 months
FIT Positive Follow-up Completion	Percent of patients with FIT+ results that complete a diagnostic colonoscopy	6 months
Colorectal Cancer (CRC) Screening Completion (Any)	Percent of patients who complete any CRC screening	6 months

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Shivan Mehta, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Actual): October 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: prevention; cancer screening; mailed FIT
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: UPCC 08222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No