Actively Recruiting

Phase Not Applicable
Age: 25Years +
All Genders
Healthy Volunteers
ID05420064

Digital Technology to Enhance Access to and Effectiveness of Cancer Genetic Counseling: Effective Familial OutReach Via Tele-genetics (EfFORT) Trial & Supporting Test Result Interpretation and Variant Education (STRIVE) Trial

Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-11-12

1000

Participants Needed

8

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating new approaches to cancer genetic counseling to improve patient engagement with genetics teams. This study includes two trials: the EfFORT Trial focuses on cascade genetic testing, where healthcare providers reach out directly to family members at risk to recommend testing, comparing it to the usual method where patients inform their relatives. The STRIVE Trial studies an online portal intervention to help patients with uncertain genetic test results and their primary care providers stay updated on new information about those results. The EfFORT Trial compares a control group where patients share a family letter with relatives against an intervention group where providers contact relatives directly, offering telegenetics counseling and at-home saliva testing. The STRIVE Trial compares standard care with a digital portal called MyGene Portal, which offers ongoing access to educational materials, communication tools, medical history updates, notifications about result reclassification, and reminders for follow-up visits. Both trials include standard post-test genetic counseling and follow-up recommendations. Participants will be involved through genetic counseling sessions, use of the online portal, and study surveys. Assessments include measuring how often genetic testing occurs in relatives and participant-perceived quality of care over 12 months. Researchers monitor engagement with the interventions, update family medical histories, and provide support for uncertain genetic results. The study is randomized and open-label, with participants actively involved in education, counseling, and communication activities throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 25Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Current patient at Memorial Sloan Kettering Cancer Center
  • Received post-test genetic counseling from MSK Clinical Genetics Service within the last 3 months (or within the last year for certain control participants)
  • 25 years of age or older
  • Understands written and spoken English or Spanish very well
  • Has at least one at-risk relative who may qualify for the study
  • First in the family to test positive for certain cancer susceptibility gene mutations or an at-risk relative of such a proband
  • Biological first-, second-, or third-degree relative of enrolled MSK proband (for at-risk relatives)
  • Resides within the United States (for at-risk relatives)
  • Has medical insurance (for at-risk relatives)
  • Primary care provider resides within the United States (for STRIVE Trial PCP providers)
Not Eligible

You will not qualify if you...

  • Unwilling or unable to provide informed consent
  • Unwilling or unable to create a MyMSK patient portal account
  • Does not have an email address
  • Enrolled in the opposite trial (EfFORT participants cannot be in STRIVE and vice versa)
  • Has previously undergone genetic testing for the familial pathogenic variant (for at-risk relatives)
  • Has opted out of study contact (for at-risk relatives)
  • Contact information not available (for STRIVE Trial primary care providers)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for eligibility assessment and consent

Behavioral Intervention

Duration - Up to 12 months

Participants receive either provider-facilitated or proband-mediated cascade genetic testing support, or digitally-facilitated follow-up through the MyGene Portal to manage genetic test results and family communication.

Ongoing engagement with study team and digital tools; pre- and post-test counseling sessions conducted via tele-genetics; saliva-based testing at home

Follow-up and Monitoring

Duration - 1 to 2 years

Participants with variants of uncertain significance (VUS) receive ongoing education and are advised to re-contact the genetics service in 1 to 2 years for updates. Engagement with personalized educational materials and family history updates continues through the MyGene Portal.

Periodic digital follow-ups and reminders; self-scheduled clinical visits as needed

Trial Site Locations

Total: 8 locations

1

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activity)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10021

Actively Recruiting

7

MSK at Ralph Lauren (Limited Protocol Activities)

New York, New York, United States, 10035

Actively Recruiting

8

Memorial Sloan Kettering Nassau (Limited Protocol Activity)

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

K

Kenneth Offit, MD, MPH

Z

Zsofia Stadler, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

5

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