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

ConditionsBRCA1 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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age25+

SponsorMemorial Sloan Kettering Cancer Center

About this trial

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."

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Intervention Arm At-risk Relative/ARR Contacts
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.
MyGene Portal
Behavioral
Through the MyGene Portal, participants will be able to continually access their genetic test results, personalized medical management recommendations from the MSK CGS care team, an interactive pedigree for personal/family history updates, and tailored educational materials for patients with a VUS in an effort to promote sustained engagement and transparency.
Standard of Care
Behavioral
Participants will received appropriate clinical care as outline by standard of care guidelines

Treatment groups

1,000 Participants

are divided into 5 treatment groups

Group A: Proband-Mediated Cascade Genetic TestingActive comparator 1 intervention

Group B: EfFORT Trial Intervention Arm: Provider-Facilitated Cascade Genetic TestingExperimental treatment 1 intervention

Group C: STRIVE Trial Control Arm: Patient-Led VUS Follow-UpActive comparator 1 intervention

Group D: STRIVE Trial Intervention Arm: Digitally-Facilitated VUS Follow-UpExperimental treatment 1 intervention

Group E: EfFORT Trial De-Identified Non-Randomized Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

The Primary Objective for EfFORT Trial: Assess genetic testing uptake by first-, second-, and third-degree relatives in the provider-facilitated cascade testing intervention as compared to the proband-mediated cascade testing control.

Time frame

12 months

Comparison of participant perceived quality of care

The Primary Objective for STRIVE Trial: Assess perceived quality of Variant of uncertain significance/VUS follow-up care and continued engagement with the Clinical Genetics Service/CGS care team in the digitally-facilitated VUS follow-up intervention as compared to the patient-led VUS follow-up control. A modified subset of items based upon an existing survey of patient-centered quality of follow-up care for cancer survivors (Cronbach's α=0.65-0.93) will be used to measure patient perceptions of the quality of their follow-up care provided by both the CGS care team (11 items) and their PCPs (6 items). Items are measured on a 4-point Likert-type scale, and mean scores are computed such that higher scores indicate greater perceived quality of care This measure will be collected from VUS patient participants in both study arms and a mean score calculated across items.

Time frame

12 months

Locations8

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Sponsors and contacts

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Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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