NCT05793593

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

March 20, 2023

Last Update Submit

July 16, 2025

Conditions

Colon Cancer Screening

Keywords

Fecal Immunochemical TestingScreening23-078

Outcome Measures

Primary Outcomes (1)

  • number of people beyond the index participants who complete FIT screening

    within 8 months of the index participant's enrollment

Study Arms (2)

Colorectal Cancer (CRC) education alone

ACTIVE COMPARATOR

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

FITx3 intervention and CRC education

EXPERIMENTAL

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

Interventions

FITx3 intervention and CRC educationOTHER

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.

FITx3 intervention and CRC education
Colorectal Cancer (CRC) education aloneOTHER

CRC education alone.

Colorectal Cancer (CRC) education alone

Eligibility Criteria

Age45 Years - 75 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memoiral Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, 11553, United States

Location

Related Links

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Francesca Gany, MD, MS

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

March 31, 2023

Study Start

March 17, 2023

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)