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Mailed FIT Outreach 2022

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05341622
Collaborator
(none)
5,460
Enrollment
1
Location
8
Arms
6
Anticipated Duration (Months)
903.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Differentiated Box
  • Behavioral: Standard Mail
  • Behavioral: Text
  • Behavioral: No Text
  • Behavioral: Reminder
  • Behavioral: No Reminder
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
5460 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Pragmatic Trial of Behavioral Interventions to Increase Response to Mailed FIT Outreach
Actual Study Start Date :
May 27, 2022
Anticipated Primary Completion Date :
Sep 27, 2022
Anticipated Study Completion Date :
Nov 27, 2022

Arms and Interventions

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: No Text
Patients will not receive text messaging explaining the importance of colon cancer screening or 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 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 Text
Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.

Behavioral: No Reminder
Patients will not receive any mailed letter reminder to complete their FIT kit.
Experimental: Arm 5: Standard Mail + Text + Reminder

Standard Mail + Text + Reminder

Behavioral: Standard Mail
Patients will receive mailed FIT in a standard mailing envelope

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 6: Standard Mail + Text + No Reminder

Standard Mail + Text + No Reminder

Behavioral: Standard Mail
Patients will receive mailed FIT in a standard mailing envelope

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 7: Standard Mail + No Text + Reminder

Behavioral: Standard Mail
Patients will receive mailed FIT in a standard mailing envelope

Behavioral: No Text
Patients will not receive text messaging explaining the importance of colon cancer screening or 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 8: Standard Mail + No Text + No Reminder

Standard Mail + No Text + No Reminder

Behavioral: Standard Mail
Patients will receive mailed FIT in a standard mailing envelope

Behavioral: No Text
Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.

Behavioral: No Reminder
Patients will not receive any mailed letter reminder to complete their FIT kit.

Outcome Measures

Primary Outcome Measures

  1. FIT Completion [4 months]

    Percent of patients who complete FIT

Secondary Outcome Measures

  1. FIT Completion [6 months]

    Percent of patients who complete FIT

  2. Colorectal Cancer (CRC) Screening Completion (any) [6 months]

    Percent of patients who complete any CRC screening

  3. FIT Positive Follow-up Scheduling [6 months]

    Percent of patients with FIT+ results that schedule a colonoscopy

  4. FIT Positive Follow-up Completion [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Penn Medicine Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Shivan Mehta, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shivan Mehta, Principal Investigator, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05341622
Other Study ID Numbers:
  • UPCC 08222
First Posted:
Apr 22, 2022
Last Update Posted:
Jul 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shivan Mehta, Principal Investigator, Abramson Cancer Center of the University of Pennsylvania
prevention
cancer screening
mailed FIT
Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms

Study Results

No Results Posted as of Jul 15, 2022