RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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."

Official Title

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

Quick Facts

Study Start:2022-12-01
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05420064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Current MSK patient
  2. * Received post-test genetic counseling from MSK Clinical Genetics Service within the last 3 months
  3. * 25 years of age or older
  4. * Self-reported "very well" comprehension of written and verbal English language
  5. * Has at least one ARR who meets criteria for study enrollment (see below)
  6. * 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:
  7. * Biological first-, second-, or third- degree relative of enrolled MSK proband
  8. * 25 years of age or older
  9. * Resides within the United States
  10. * Self-reported medical insurance which can be in or out of network with MSK
  11. * Self-reported "very well" comprehension of written and verbal English language
  12. * Current MSK patient
  13. * Received post-test genetic counseling from MSK Clinical Genetics Service within the last 3 months
  14. * 25 years of age or older
  15. * Self-reported "very well" comprehension of written and verbal English language
  16. * Has a VUS identified in any of the following cancer predisposition genes:
  17. * Designated healthcare provider for an enrolled VUS patient
  18. * Resides within the United States
  1. * Is unwilling or unable to provide informed consent
  2. * Is unwilling or unable to create a MyMSK patient portal account (see section 3.0 on MyMSK patient usage at MSK and CGS)
  3. * Does not have an email address
  4. * Has enrolled in the STRIVE trial
  5. * Is unwilling or unable to provide informed consent
  6. * Is unwilling or unable to create a MyMSK patient portal account
  7. * Has previously undergone genetic testing for the familial PV
  8. * Does not have an email address
  9. * Has opted out of study contact
  10. * Is unwilling or unable to provide informed consent
  11. * Is unwilling or unable to create a MyMSK patient portal account (see section 3.0 on MyMSK patient usage at MSK and CGS)
  12. * Does not have an email address
  13. * Has enrolled in the EfFORT trial
  14. * Contact information not available

Contacts and Locations

Study Contact

Kenneth Offit, MD, MPH
CONTACT
646-888-4059
offitk@mskcc.org
Zsofia Stadler, MD
CONTACT
646-888-4039
stadlerz@mskcc.org

Principal Investigator

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

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activity)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
United States
MSK at Ralph Lauren (Limited Protocol Activities)
New York, New York, 10035
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activity)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-01
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2022-12-01
Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

  • EfFORT
  • Memorial Sloan Kettering Cancer Center
  • Genetic Testing
  • 22-023

Additional Relevant MeSH Terms

  • 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