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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,938 Previous Clinical Trials

585,785 Total Patients Enrolled

77 Trials studying Melanoma

15,978 Patients Enrolled for Melanoma

Kenneth Offit, MD, MPHPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

6,965 Total Patients Enrolled

Media Library

Intervention Arm At-risk Relative/ARR Contacts (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05420064 — N/A

Melanoma Research Study Groups: EfFORT Trial Intervention Arm: Provider-Facilitated Cascade Genetic Testing, STRIVE Trial Control Arm: Patient-Led VUS Follow-Up, STRIVE Trial Intervention Arm: Digitally-Facilitated VUS Follow-Up, Proband-Mediated Cascade Genetic Testing

Melanoma Clinical Trial 2023: Intervention Arm At-risk Relative/ARR Contacts Highlights & Side Effects. Trial Name: NCT05420064 — N/A

Intervention Arm At-risk Relative/ARR Contacts (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05420064 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the participant size of this trial?

"Affirmative, according to clinicaltrials.gov the trial is actively recruiting patients with an initial post date of December 1st 2022 and a recent update on April 6th 2023. The number of participants needed spans 8 locations and totals 896 individuals."

Answered by AI

Are there any slots still open for prospective participants in this experiment?

"According to clinicaltrials.gov, this research is actively looking for participants at the moment. The trial was first debuted on December 1st 2022 and was recently updated on April 6th 2023."

Answered by AI

How many medical facilities are participating in the research endeavor?

"8 different clinical sites are now recruiting patients for this medical trial, such as Memorial Sloan Kettering Nassau (Limited Protocol Activity) in Uniondale and Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities). Additionally, there is availability at 6 other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk

2022. "An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05420064.

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