AzTrials
AzTrials

Colorectal CancerNCT05341622

Mailed FIT Outreach 2022

A study testing Differentiated Box, Standard Mail and Text in people with Colorectal Cancer and Colon Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 50 to 74 years
Conditions the study is for
Colorectal Cancer, Colon Cancer
What is being tested?
Differentiated Box, Standard Mail and Text
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,460 participants
Where
1 siteUnited States
Study dates
27 May 2022to 13 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Pragmatic Trial of Behavioral Interventions to Increase Response to Mailed FIT Outreach

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.

Read the 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.

Being tested
Differentiated Box, Standard Mail, Text, No Text, Reminder
Keywords
prevention, cancer screening, mailed FIT
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Differentiated BoxBehavioural

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

  • Standard MailBehavioural

    Patients will receive mailed FIT in a standard mailing envelope

  • TextBehavioural

    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 TextBehavioural

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

  • ReminderBehavioural

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

  • No ReminderBehavioural

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

Study groups in NCT05341622
Study groupRoleWhat they receive
Arm 1: Box + Text + ReminderExperimentalBox + Text + Reminder
Receives: Behavioral: Differentiated Box; Behavioral: Text; Behavioral: Reminder
Arm 2: Box + Text + No ReminderExperimentalBox + Text + No Reminder
Receives: Behavioral: Differentiated Box; Behavioral: Text; Behavioral: No Reminder
Arm 3: Box + No Text + ReminderExperimentalBox + No Text + Reminder
Receives: Behavioral: Differentiated Box; Behavioral: No Text; Behavioral: Reminder
Arm 4: Box + No Text + No ReminderExperimentalBox + No Text + No Reminder
Receives: Behavioral: Differentiated Box; Behavioral: No Text; Behavioral: No Reminder
Arm 5: Standard Mail + Text + ReminderExperimentalStandard Mail + Text + Reminder
Receives: Behavioral: Standard Mail; Behavioral: Text; Behavioral: Reminder
Arm 6: Standard Mail + Text + No ReminderExperimentalStandard Mail + Text + No Reminder
Receives: Behavioral: Standard Mail; Behavioral: Text; Behavioral: No Reminder
Arm 7: Standard Mail + No Text + ReminderExperimentalNot described
Receives: Behavioral: Standard Mail; Behavioral: No Text; Behavioral: Reminder
Arm 8: Standard Mail + No Text + No ReminderExperimentalStandard Mail + No Text + No Reminder
Receives: Behavioral: Standard Mail; Behavioral: No Text; Behavioral: No Reminder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FIT Completion

    Percent of patients who complete FIT

    Measured: 4 months

Secondary outcomes (4)

  1. FIT Completion

    Percent of patients who complete FIT

    Measured: 6 months

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

    Percent of patients who complete any CRC screening

    Measured: 6 months

  3. FIT Positive Follow-up Scheduling

    Percent of patients with FIT+ results that schedule a colonoscopy

    Measured: 6 months

  4. FIT Positive Follow-up Completion

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2022
  2. Study start27 May 2022
  3. Primary completion13 Oct 2022
  4. Study completion13 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
5,460 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05341622
Sponsor's protocol ID
UPCC 08222
Status last verified
Jul 2024
First submitted
18 Apr 2022
Last updated
24 Jul 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mehta SJ, Nadella P, Shaw PA, Reitz C, Brophy C, Okorie E, Williams K, Snider CK, Peifer MK, Rhodes C, Asch DA. Behavioral Interventions Improve Mailed Colorectal Cancer Screening Among Overdue Patients in a Randomized Trial. Clin Gastroenterol Hepatol. 2026 May;24(5):1442-1451. doi: 10.1016/j.cgh.2025.09.015. Epub 2025 Sep 20.

    PubMed 40983155

Questions about this trial

What is this clinical trial studying?

A study testing Differentiated Box, Standard Mail and Text in people with Colorectal Cancer and Colon Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FIT Completion (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05341622, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Mailed FIT Outreach 2022 (NCT05341622) | AzTrials