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Study on Improving Genetic Testing for Cancer Risk

This study is looking at new ways to help families understand and get genetic testing for cancer risk. It focuses on two main interventions: the "Intervention Arm At-risk Relative/ARR Contacts" and the "MyGene Portal." The first intervention involves healthcare providers reaching out to family members who might share a cancer-related gene mutation (like BRCA1 or BRCA2) to offer genetic testing. The MyGene Portal is an online tool where you can access your genetic test results, personalized medical advice, and educational materials. The study aims to see how these approaches affect how many people get tested and their overall experience with care. To join, you need to be at least 25 years old, an MSK patient, and have had genetic counseling recently. You also need to speak English or Spanish very well and have at least one at-risk family member.

Study design
This is an interventional study with a planned enrollment of 1000 participants. It compares different ways of offering genetic testing to family members.
What's involved
Participants will either provide contact information for at-risk relatives or use the MyGene Portal to access their genetic information and updates. Standard medical care will also be provided.
Compensation
Not stated in the trial record.
Follow-up
The study will compare genetic testing uptake and participant-perceived quality of care at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05420064

An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk and An Intervention to Help Patients and Their Primary Care Providers Stay Up-to-date About Uncertain Genetic Test Results

Recruiting
NAAges 25+InterventionalHealth services
Memorial Sloan Kettering Cancer Center
~1,000 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Intervention Arm At-risk Relative/ARR ContactsMyGene PortalStandard of Care

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of genetic testing uptake in provider-facilitated cascade testing intervention to the proband-mediated cascade testing control
Measured over 12 months
+1 more outcome measured

Conditions

BRCA1 Mutation
POLD1 Gene Mutation
CDKN2A Mutation
BRCA2 Mutation
POLE Gene Mutation
APC Gene Mutation
ATM Gene Mutation
MLH1 Gene Mutation
BARD1 Gene Mutation
MSH2 Gene Mutation
BRIP1 Gene Mutation
MSH6 Gene Mutation
CHEK2 Gene Mutation
PMS2 Gene Mutation
PALB2 Gene Mutation
EPCAM Gene Mutation
RAD51C Gene Mutation
BMPR1A Gene Mutation
RAD51D Gene Mutation
SMAD4
PTEN Gene Mutation
GREM1

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NCT05420064

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activity)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activity)

    Uniondale, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New Yorkstudy coordinator listed

    Recruiting

  • MSK at Ralph Lauren (Limited Protocol Activities)

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kenneth Offit, MD, MPH · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Kenneth Offit, MD, MPH
[email protected]
646-888-4059
Email the study team

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Eligibility criteria

Inclusion

Current MSK patient
Received post-test genetic counseling from MSK Clinical Genetics Service within the last 3 months (or within the last year for the de-identified non-randomized control probands)
25 years of age or older
Self-reported "very well" comprehension of written and verbal English language or Spanish language
Has at least one ARR who meets criteria for study enrollment (see below)
First in the family to test positive for PV at MSK in any of the following cancer susceptibility genes, or an ARR of an MSK proband who converted to the proband role:
Biological first-, second-, or third- degree relative of enrolled MSK proband
25 years of age or older
Resides within the United States
Self-reported medical insurance which can be in or out of network with MSK
Self-reported "very well" comprehension of written and verbal English language
Current MSK patient
Received post-test genetic counseling from MSK Clinical Genetics Service within the last 3 months
25 years of age or older
Self-reported "very well" comprehension of written and verbal English language or Spanish language
Has a VUS identified in any of the following cancer predisposition genes:
Designated healthcare provider for an enrolled VUS patient
Resides within the United States

Exclusion

Is unwilling or unable to provide informed consent
Is unwilling or unable to create a MyMSK patient portal account (see section 3.0 on MyMSK patient usage at MSK and CGS)
Does not have an email address
Has enrolled in the STRIVE trial
Is unwilling or unable to provide informed consent
Is unwilling or unable to create a MyMSK patient portal account
Has previously undergone genetic testing for the familial PV
Does not have an email address
Has opted out of study contact
Is unwilling or unable to provide informed consent
Is unwilling or unable to create a MyMSK patient portal account (see section 3.0 on MyMSK patient usage at MSK and CGS)
Does not have an email address
Has enrolled in the EfFORT trial
Contact information not available

What this trial measures

  • Comparison of genetic testing uptake in provider-facilitated cascade testing intervention to the proband-mediated cascade testing control12 months

    The Primary Objective for EfFORT Trial: Assess genetic testing uptake by first-, second-, and third-degree relatives in the provider-facilitated cascade testing intervention as compared to the proband-mediated cascade testing control.

  • Comparison of participant perceived quality of care12 months

    The Primary Objective for STRIVE Trial: Assess perceived quality of Variant of uncertain significance/VUS follow-up care and continued engagement with the Clinical Genetics Service/CGS care team in the digitally-facilitated VUS follow-up intervention as compared to the patient-led VUS follow-up control. A modified subset of items based upon an existing survey of patient-centered quality of follow-up care for cancer survivors (Cronbach's α=0.65-0.93) will be used to measure patient perceptions of the quality of their follow-up care provided by both the CGS care team (11 items) and their PCPs (6 items). Items are measured on a 4-point Likert-type scale, and mean scores are computed such that higher scores indicate greater perceived quality of care This measure will be collected from VUS patient participants in both study arms and a mean score calculated across items.