Mailed FIT Outreach 2022

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Colon Cancer; Colorectal Cancer

Treatments: Behavioral: No Text; Behavioral: Standard Mail; Behavioral: No Reminder; Behavioral: Differentiated Box; Behavioral: Reminder; Behavioral: Text

Study type: Interventional

Funder types: Other

Identifiers

NCT05341622

UPCC 08222

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,460 patients

Sex: All

Ages: 50 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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5,460 participants in 8 patient groups

Arm 1: Box + Text + Reminder

Experimental group

Description:

Box + Text + Reminder

Treatment:

Behavioral: Text

Behavioral: Reminder

Behavioral: Differentiated Box

Arm 2: Box + Text + No Reminder

Experimental group

Description:

Box + Text + No Reminder

Treatment:

Behavioral: Text

Behavioral: No Reminder

Behavioral: Differentiated Box

Arm 3: Box + No Text + Reminder

Experimental group

Description:

Box + No Text + Reminder

Treatment:

Behavioral: Reminder

Behavioral: Differentiated Box

Behavioral: No Text

Arm 4: Box + No Text + No Reminder

Experimental group

Description:

Box + No Text + No Reminder

Treatment:

Behavioral: No Reminder

Behavioral: Differentiated Box

Behavioral: No Text

Arm 5: Standard Mail + Text + Reminder

Experimental group

Description:

Standard Mail + Text + Reminder

Treatment:

Behavioral: Text

Behavioral: Reminder

Behavioral: Standard Mail

Arm 6: Standard Mail + Text + No Reminder

Experimental group

Description:

Standard Mail + Text + No Reminder

Treatment:

Behavioral: Text

Behavioral: No Reminder

Behavioral: Standard Mail

Arm 7: Standard Mail + No Text + Reminder

Experimental group

Treatment:

Behavioral: Reminder

Behavioral: Standard Mail

Behavioral: No Text

Arm 8: Standard Mail + No Text + No Reminder

Experimental group

Description:

Standard Mail + No Text + No Reminder

Treatment:

Behavioral: No Reminder

Behavioral: Standard Mail

Behavioral: No Text