A Study of Using Social Networks to Encourage Three Peers to Complete Screening for Colorectal Cancer

April 1, 2026 updated by: Memorial Sloan Kettering Cancer Center

FITx3 RCT: A Pilot Randomized Controlled Trial Leveraging Social Networks to Encourage Three Peers to Complete Fecal Immunochemical Testing for Colorectal Cancer

The Black community has higher rates of colorectal cancer and lower rates of colorectal cancer screenings than whites. Getting screened through FIT testing may help catch colorectal cancer earlier, when it is easier to treat. MSK has created a program to help people who have been FIT tested to also help their peers (family, friends, and colleagues) in their community get FIT tested. The researchers think that training people on peer outreach, such as telling people in your social network about FIT testing and how to get it, may increase the rate of colorectal cancer screening. The purpose of this study is to see if training people on peer outreach increases the number of people who get screened for colorectal cancer through FIT testing.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memoiral Sloan Kettering Basking Ridge (All Protocol Activities)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (All protocol activities)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (All protocol activities)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester (All protocol activities)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Rockville Centre, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (All protocol activities)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Self-identifies as Black (inclusive of African, African-American, or Afro-Caribbean)
  • Male
  • Speaks English or French very well
  • Is at least 45 years of age and no greater than 75 years of age
  • Has completed FIT testing within the prior year
  • Has at least 5 close network affiliates, who are Black males, and of at least 45 years of age and no greater than 75 years of age

Exclusion Criteria:

  • Has a household member who has already participated (or agreed to participate)
  • Has already been approached by a peer participating in the study (index participant) to complete FIT testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Colorectal Cancer (CRC) education alone
All participants will be educated, on a simplified clinical and medical background of CRC; causes and risk factors for CRC; eligibility criteria for screening; lifestyle modifications to lower risk of developing CRC; screening methods for CRC, including FIT and colonoscopy; addressing myths and misconceptions about CRC; and information about resources for low-cost and no-cost screening, screening for the uninsured and screening for those without legal immigration documentation. Participants will also be educated on elements of fecal immunochemical testing (detects signs of cancer in the stool, can be done at home and sent to a laboratory for analysis, needs to be done yearly to ensure maximal effectiveness for cancer screening). Follow-up Assessment at 8 months complete follow-up form and assist in completion of peer outreach tracker Provide reminders to encourage participants to encourage peers to get FIT tested.
Other: Colorectal Cancer (CRC) education alone
CRC education alone.
Experimental: FITx3 intervention and CRC education
Provide CRC education, SN education, handouts and text message/social media posts example library. Monthly Telephone Support Provide any additional support to index participants for peer FIT testing, assist in completion of peer outreach tracker. Biweekly Text Messages. Follow-up Assessment (month 8 after intervention) Complete follow-up form and assist in completion of peer outreach tracker Provide reminders to encourage participants to encourage peers to get FIT tested.
Other: FITx3 intervention and CRC education
Provide CRC education, SN education, handouts and text message/social media posts example library. Monthly Telephone Support Provide any additional support to index participants for peer FIT testing, assist in completion of peer outreach tracker. Biweekly Text Messages. Follow-up Assessment (month 8 after intervention) Complete follow-up form and assist in completion of peer outreach tracker Provide reminders to encourage participants to encourage peers to get FIT tested.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of people beyond the index participants who complete FIT screening
Time Frame: within 8 months of the index participant's enrollment
within 8 months of the index participant's enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

CANCER PREVENTION FUND

Investigators

  • Principal Investigator: Francesca Gany, MD, MS, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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