Back to resultsA Study of Using Social Networks to Encourage Three Peers to Complete Screening for Colorectal Cancer
Primary Purpose
Colon Cancer Screening
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FITx3 intervention and CRC education
Colorectal Cancer (CRC) education alone
Sponsored by
About this trial
This is an interventional prevention trial for Colon Cancer Screening focused on measuring Fecal Immunochemical Testing, Screening, 23-078
Eligibility Criteria
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
Sites / Locations
- Memoiral Sloan Kettering Basking Ridge (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Bergen (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Nassau (All Protocol Activities)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Colorectal Cancer (CRC) education alone
FITx3 intervention and CRC education
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
number of people beyond the index participants who complete FIT screening
Secondary Outcome Measures
Full Information
NCT ID
NCT05793593
First Posted
March 20, 2023
Last Updated
August 3, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
CANCER PREVENTION FUND
1. Study Identification
Unique Protocol Identification Number
NCT05793593
Brief Title
A Study of Using Social Networks to Encourage Three Peers to Complete Screening for Colorectal Cancer
Official Title
FITx3 RCT: A Pilot Randomized Controlled Trial Leveraging Social Networks to Encourage Three Peers to Complete Fecal Immunochemical Testing for Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
CANCER PREVENTION FUND
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Screening
Keywords
Fecal Immunochemical Testing, Screening, 23-078
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Colorectal Cancer (CRC) education alone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
FITx3 intervention and CRC education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
FITx3 intervention and CRC education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Colorectal Cancer (CRC) education alone
Intervention Description
CRC education alone.
Primary Outcome Measure Information:
Title
number of people beyond the index participants who complete FIT screening
Time Frame
within 8 months of the index participant's enrollment
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Gany, MD, MS
Phone
646-888-8054
Email
ganyf@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Leng, MD, MPH
Phone
646-888-8057
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesca Gany, MD, MS
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoiral Sloan Kettering Basking Ridge (All Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Gany, MD, MS
Phone
646-888-8054
Facility Name
Memorial Sloan Kettering Monmouth (All Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fransecsa Gany, MD, MS
Phone
646-888-8054
Facility Name
Memorial Sloan Kettering Bergen (All Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Gany, MD, MS
Phone
646-888-8054
Facility Name
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Gany, MD, MS
Phone
646-888-8054
Facility Name
Memorial Sloan Kettering Westchester (All Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Gany, MD, MS
Phone
646-888-8054
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Gany, MD, MS
Phone
646-888-8054
Facility Name
Memorial Sloan Kettering Nassau (All Protocol Activities)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franscesca Gany, MD, MS
Phone
646-888-8054
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
A Study of Using Social Networks to Encourage Three Peers to Complete Screening for Colorectal Cancer
We'll reach out to this number within 24 hrs