Back to results

Mailed FIT Outreach 2022

Primary Purpose

Colorectal Cancer, Colon Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Differentiated Box

Standard Mail

Text

No Text

Reminder

No Reminder

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring prevention, cancer screening, mailed FIT

Eligibility Criteria

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

Inclusion Criteria:

Patients ages 50-74 with Penn as preferred lab
Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
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:

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
History of total colectomy, dementia or metastatic cancer
Currently on hospice or receiving palliative care
Uninsured or self-pay patients
Currently scheduled for a colonoscopy or sigmoidoscopy

Sites / Locations

Penn Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Arm 1: Box + Text + Reminder

Arm 2: Box + Text + No Reminder

Arm 3: Box + No Text + Reminder

Arm 4: Box + No Text + No Reminder

Arm 5: Standard Mail + Text + Reminder

Arm 6: Standard Mail + Text + No Reminder

Arm 7: Standard Mail + No Text + Reminder

Arm 8: Standard Mail + No Text + No Reminder

Arm Description

Box + Text + Reminder

Box + Text + No Reminder

Box + No Text + Reminder

Box + No Text + No Reminder

Standard Mail + Text + Reminder

Standard Mail + Text + No Reminder

Standard Mail + No Text + No Reminder

Outcomes

Primary Outcome Measures

FIT Completion

Percent of patients who complete FIT

Secondary Outcome Measures

FIT Completion

Percent of patients who complete FIT

Colorectal Cancer (CRC) Screening Completion (any)

Percent of patients who complete any CRC screening

FIT Positive Follow-up Scheduling

Percent of patients with FIT+ results that schedule a colonoscopy

FIT Positive Follow-up Completion

Percent of patients with FIT+ results that complete a diagnostic colonoscopy

Full Information

NCT ID

NCT05341622

First Posted

April 18, 2022

Last Updated

January 27, 2023

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05341622

Brief Title

Mailed FIT Outreach 2022

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

May 27, 2022 (Actual)

Primary Completion Date

October 13, 2022 (Actual)

Study Completion Date

December 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Colon Cancer

Keywords

prevention, cancer screening, mailed FIT

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

5460 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Box + Text + Reminder

Arm Type

Experimental

Arm Description

Box + Text + Reminder

Arm Title

Arm 2: Box + Text + No Reminder

Arm Type

Experimental

Arm Description

Box + Text + No Reminder

Arm Title

Arm 3: Box + No Text + Reminder

Arm Type

Experimental

Arm Description

Box + No Text + Reminder

Arm Title

Arm 4: Box + No Text + No Reminder

Arm Type

Experimental

Arm Description

Box + No Text + No Reminder

Arm Title

Arm 5: Standard Mail + Text + Reminder

Arm Type

Experimental

Arm Description

Standard Mail + Text + Reminder

Arm Title

Arm 6: Standard Mail + Text + No Reminder

Arm Type

Experimental

Arm Description

Standard Mail + Text + No Reminder

Arm Title

Arm 7: Standard Mail + No Text + Reminder

Arm Type

Experimental

Arm Title

Arm 8: Standard Mail + No Text + No Reminder

Arm Type

Experimental

Arm Description

Standard Mail + No Text + No Reminder

Intervention Type

Behavioral

Intervention Name(s)

Differentiated Box

Intervention Description

Patients will receive mailed FIT kits in a box with differentiated packaging

Intervention Type

Behavioral

Intervention Name(s)

Standard Mail

Intervention Description

Patients will receive mailed FIT in a standard mailing envelope

Intervention Type

Behavioral

Intervention Name(s)

Text

Intervention Description

Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.

Intervention Type

Behavioral

Intervention Name(s)

No Text

Intervention Description

Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.

Intervention Type

Behavioral

Intervention Name(s)

Reminder

Intervention Description

Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.

Intervention Type

Behavioral

Intervention Name(s)

No Reminder

Intervention Description

Patients will not receive any mailed letter reminder to complete their FIT kit.

Primary Outcome Measure Information:

Title

FIT Completion

Description

Percent of patients who complete FIT

Time Frame

4 months

Secondary Outcome Measure Information:

Title

FIT Completion

Description

Percent of patients who complete FIT

Time Frame

6 months

Title

Colorectal Cancer (CRC) Screening Completion (any)

Description

Percent of patients who complete any CRC screening

Time Frame

6 months

Title

FIT Positive Follow-up Scheduling

Description

Percent of patients with FIT+ results that schedule a colonoscopy

Time Frame

6 months

Title

FIT Positive Follow-up Completion

Description

Percent of patients with FIT+ results that complete a diagnostic colonoscopy

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients ages 50-74 with Penn as preferred lab Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years 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: 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 History of total colectomy, dementia or metastatic cancer Currently on hospice or receiving palliative care Uninsured or self-pay patients Currently scheduled for a colonoscopy or sigmoidoscopy

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

Penn Medicine

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Mailed FIT Outreach 2022

We'll reach out to this number within 24 hrs