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Behavioral Intervention

Genetic Testing Intervention for Cancer Risk

N/A

Recruiting

Led By Kenneth Offit, MD, MPH

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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: BRCA1, POLD1, CDKN2A (P16), BRCA2, POLE, APC I1307K, ATM, MLH1, BARD1, MSH2, BRIP1, MSH6, CHEK2, PMS2, PALB2, EPCAM, RAD51C, BMPR1A, RAD51D, SMAD4, PTEN, GREM1

25 years of age or older

Must not have

Does not have an email address

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the effectiveness of healthcare providers reaching out to family members to recommend genetic testing for inherited diseases.

Who is the study for?

This trial is for adults over 25 who are patients at MSK, have recently received genetic counseling there, and understand English. They must have a relative also eligible to join. It's for those with certain gene mutations linked to cancer risk or relatives of such individuals. People can't join if they're unable or unwilling to consent, use the MyMSK patient portal, or don't have an email address.

What is being tested?

The study tests a 'cascade' approach where healthcare providers contact family members directly about genetic testing for inherited cancer risks versus the usual method of patients informing their relatives themselves.

What are the potential side effects?

Since this trial involves genetic testing rather than medication or surgery, traditional side effects aren't expected. However, participants may experience emotional or psychological impacts from learning about their genetic risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am the first in my family to test positive for a specific cancer gene at MSK.

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I am 25 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an email address.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of genetic testing uptake in provider-facilitated cascade testing intervention to the proband-mediated cascade testing control

Comparison of participant perceived quality of care

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: STRIVE Trial Intervention Arm: Digitally-Facilitated VUS Follow-UpExperimental Treatment1 Intervention

Following standard of care post-test genetic counseling, patients will be provided access to the MyGene Portal. Through this portal, participants will be able to continuously engage with interactive educational materials including information about Variant of uncertain significance/VUS results and recommendations, access tools for participants to communicate with the CGS team, access the interactive pedigree (FamGenix) to provide updates about personal/family medical history, receive notifications about VUS reclassification, and receive reminders to self-schedule a follow-up clinical visit to discuss updates. In this way, participants will have a transparent, ongoing, and structured follow-up plan for their VUS management.

Group II: EfFORT Trial Intervention Arm: Provider-Facilitated Cascade Genetic TestingExperimental Treatment1 Intervention

Intervention arm-: Behavioral: Probands will give contact info for their ARR in the eDGP and indicate a date by which they will discuss the familial pathogenic variant with their ARR (can request a delay/halt to outreach). After this date the team will contact the ARR to invite them to review education and e-consent to the study. The study team will facilitate ARR cascade testing through telegenetics pre- and post-test counseling and saliva-based at home testing through MSK or a reference laboratory.

Group III: STRIVE Trial Control Arm: Patient-Led VUS Follow-UpActive Control1 Intervention

Patients will receive standard of care post-test genetic counseling and discussion of implications for relatives, if any. Consistent with standard practice, most patients will likely be recommended against telling their relatives to seek genetic testing for the Variant of uncertain significance/VUS because it is not clinically useful. All participants with a VUS will be recommended to re-contact the MSK CGS in 1-2 years for updated information related to the VUS result

Group IV: Proband-Mediated Cascade Genetic TestingActive Control2 Interventions

Control arm- Behavioral: As per standard of care, probands will be given a Family Letter by their genetic counselor that they will be instructed to share with their at-risk relatives (ARR). In addition to the recommendation that ARR undergo genetic counseling and a list of local genetics clinics, this letter will include a link to the eDGP through which control ARR can enroll onto the present study. For these ARR, the eDGP will only be used to obtain study e-consent and to administer study surveys.

0 / 3Eligibility criteria met