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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

RecruitingNAAges 25 Years - anyAllMemorial Sloan Kettering Cancer Center
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: EfFORT Trial Probands * 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: APC I1307K, ATM, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDKN2A (P16), CHEK2, EPCAM, GREM1, MLH1, MSH2, MSH6, PALB2, PMS2, POLD1, POLE, PTEN, RAD51C, RAD51D, SMAD4, BAP1, DICER1, FH, FLCN, HOXB13, KIT, MAX, MEN1, MET, MITF, PTCH1, RAD51B, RET, SDHB, SDHC, SDHD, STK11, SUFU, TMEM127, TSC1, TSC2, VHL Principal Investigator discretion will be used to determine whether specific variants within the above genes meet a clinical actionability threshold to warrant familial genetic testing. EfFORT Trial At-Risk Relatives (ARRs): * 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 STRIVE Trial VUS Patients * 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: APC, ATM, AXIN2, BAP1, BARD1, BLM, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A (P16), CHEK2, CTNNA1, DICER1, ELOC, EPCAM, FH, FLCN, GREM1, HOXB13, KEAP1, MAX, MBD4, MEN1, MET, MITF, MLH1, MLH3, MSH2, MSH3, MSH6, MUTYH, NF1, NF2, NTHL1, PALB2, PMS2, POLD1, POLE, POT1, PTEN, RAD51B, RAD51C, RAD51D, RB1, RET, RNF43, RPS20, SDHA, SDHAF2, SDHB, SDHC, SDHD, SMAD4, STK11, TERT, TMEM127, TP53, TSC1, TSC2, VHL STRIVE Trial PCP Providers: * Designated healthcare provider for an enrolled VUS patient * Resides within the United States Exclusion Criteria: EfFORT Trial Probands * 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 EfFORT Trial At-Risk Relatives (ARRs): * 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 STRIVE Trial VUS Patients * 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 STRIVE Trial PCP Providers * Contact information not available
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What it tests

  • Intervention Arm At-risk Relative/ARR Contacts
  • MyGene Portal
  • Standard of Care
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Where

8 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activity)
Montvale, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, United States
Memorial Sloan Kettering Cancer Center
New York, United States
MSK at Ralph Lauren (Limited Protocol Activities)
New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activity)
Uniondale, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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