Mailed FIT Outreach 2022

Not Applicable

Completed

• Conditions: Colon Cancer; Colorectal Cancer
• Interventions: Behavioral: Differentiated Box; Behavioral: Standard Mail; Behavioral: Text; Behavioral: No Text; Behavioral: No Reminder; Behavioral: Reminder

• Registration Number: NCT05341622
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-22
• Study Start: 2022-05-27
• Primary Completion: 2022-10-13
• Study Completion: 2022-12-13
• Results First Submitted: 2024-01-05
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Results First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5460

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm 1: Box + Text + Reminder	Text	Box + Text + Reminder
Arm 2: Box + Text + No Reminder	Differentiated Box	Box + Text + No Reminder
Arm 2: Box + Text + No Reminder	Text	Box + Text + No Reminder
Arm 2: Box + Text + No Reminder	No Reminder	Box + Text + No Reminder
Arm 3: Box + No Text + Reminder	No Text	Box + No Text + Reminder
Arm 4: Box + No Text + No Reminder	Differentiated Box	Box + No Text + No Reminder
Arm 4: Box + No Text + No Reminder	No Text	Box + No Text + No Reminder
Arm 4: Box + No Text + No Reminder	No Reminder	Box + No Text + No Reminder
Arm 5: Standard Mail + Text + Reminder	Text	Standard Mail + Text + Reminder
Arm 5: Standard Mail + Text + Reminder	Reminder	Standard Mail + Text + Reminder
Arm 6: Standard Mail + Text + No Reminder	Standard Mail	Standard Mail + Text + No Reminder
Arm 6: Standard Mail + Text + No Reminder	No Reminder	Standard Mail + Text + No Reminder
Arm 7: Standard Mail + No Text + Reminder	Standard Mail	-
Arm 7: Standard Mail + No Text + Reminder	No Text	-
Arm 8: Standard Mail + No Text + No Reminder	Standard Mail	Standard Mail + No Text + No Reminder
Arm 8: Standard Mail + No Text + No Reminder	No Text	Standard Mail + No Text + No Reminder
Arm 3: Box + No Text + Reminder	Differentiated Box	Box + No Text + Reminder
Arm 1: Box + Text + Reminder	Differentiated Box	Box + Text + Reminder
Arm 3: Box + No Text + Reminder	Reminder	Box + No Text + Reminder
Arm 5: Standard Mail + Text + Reminder	Standard Mail	Standard Mail + Text + Reminder
Arm 6: Standard Mail + Text + No Reminder	Text	Standard Mail + Text + No Reminder
Arm 7: Standard Mail + No Text + Reminder	Reminder	-
Arm 8: Standard Mail + No Text + No Reminder	No Reminder	Standard Mail + No Text + No Reminder
Arm 1: Box + Text + Reminder	Reminder	Box + Text + Reminder

Primary Outcome Measures

Name	Time	Method
FIT Completion	4 months	Percent of patients who complete FIT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Penn Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States