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OpenTrials
Completed

NCT Number: NCT05341622

Mailed FIT Outreach 2022

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.

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Key information

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Differentiated Box

Behavioral

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

Standard Mail

Behavioral

Patients will receive mailed FIT in a standard mailing envelope

Text

Behavioral

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

Behavioral

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

Reminder

Behavioral

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

No Reminder

Behavioral

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

Primary outcomes

  1. FIT Completion

    Time frame: 4 months

    Percent of patients who complete FIT

Secondary outcomes

  1. FIT Completion

    Time frame: 6 months

    Percent of patients who complete FIT

  2. Colorectal Cancer (CRC) Screening Completion (Any)

    Time frame: 6 months

    Percent of patients who complete any CRC screening

  3. FIT Positive Follow-up Scheduling

    Time frame: 6 months

    Percent of patients with FIT+ results that schedule a colonoscopy

  4. FIT Positive Follow-up Completion

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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