Actively Recruiting

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

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

1000

Participants Needed

8

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to examine the impact of new cancer genetic counseling models that aim to increase patient engagement with the genetics team. To do this, the study consists of two trials to evaluate two related interventions. The first trial is the EfFORT Trial, which evaluates a cascade genetic testing intervention. Cascade testing is the process of offering genetic testing to people who are at risk of having inherited a possibly harmful gene change that has been found in their family. The study will look at how often genetic testing occurs when healthcare providers have permission to reach out to family members to recommend genetic testing and to help those who are interested get tested. The study will look at whether this cascade testing intervention is practical and effective. The study would like to see how this approach of healthcare providers reaching out directly to family members compares with the usual approach of patients telling their family members about the recommendation to get genetic testing. The second trial is the STRIVE Trial, which evaluates an intervention designed to help patients who receive an uncertain result from genetic testing (also called a "variant of uncertain significance") stay connected with their genetics care team, and to help patients and their primary care providers stay up-to-date about the meaning of uncertain genetic test results. The study will look at whether an intervention that consists of a study online portal for patients with uncertain genetic test results and their primary care providers will help them to stay up-to-date on the meaning of uncertain genetic test results. The study would like to see how this intervention compares to the usual approach of encouraging patients to re-contact their genetics care team on their own about a year after getting genetic testing."

CONDITIONS

Official 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 MSK patient
  • Received post-test genetic counseling from MSK Clinical Genetics Service within the last 3 months (or within the last year for de-identified non-randomized controls)
  • 25 years of age or older
  • Very well comprehension of written and verbal English or Spanish
  • Has at least one at-risk relative who meets study enrollment criteria
  • First in family to test positive for pathogenic variant in specified cancer genes or an at-risk relative of such proband
  • At-risk relatives must be biological first-, second-, or third-degree relatives, 25 years or older, residing in the United States, have medical insurance, and comprehend English very well
  • Patients with variant of uncertain significance (VUS) in specified cancer predisposition genes
  • Primary care providers designated for enrolled VUS patients residing in the United States
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 alternate trial (EfFORT probands excluded if enrolled in STRIVE and vice versa)
  • At-risk relatives previously tested for familial pathogenic variant
  • At-risk relatives who have opted out of study contact
  • Primary care providers without available contact information

AI-Screening

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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

CONTACT

Z

Zsofia Stadler, MD

CONTACT

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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