Mailed FIT Outreach 2022

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05341622
• Other study ID #: UPCC 08222
• Status: Completed
• Phase: N/A
• Start date: May 27, 2022
• Est. completion date: December 13, 2022

Study information

• Verified date: January 2023
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5460
• Est. completion date: December 13, 2022
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Differentiated Box
Patients will receive mailed FIT kits in a box with differentiated packaging
• Standard Mail
Patients will receive mailed FIT in a standard mailing envelope
• 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.
• No Text
Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
• Reminder
Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
• No Reminder
Patients will not receive any mailed letter reminder to complete their FIT kit.

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FIT Completion	Percent of patients who complete FIT	4 months
Secondary	FIT Completion	Percent of patients who complete FIT	6 months
Secondary	Colorectal Cancer (CRC) Screening Completion (any)	Percent of patients who complete any CRC screening	6 months
Secondary	FIT Positive Follow-up Scheduling	Percent of patients with FIT+ results that schedule a colonoscopy	6 months
Secondary	FIT Positive Follow-up Completion	Percent of patients with FIT+ results that complete a diagnostic colonoscopy	6 months