This clinical trial tests how well a linguistically and culturally appropriate mainstreaming (LCAM) model for hereditary cancer multigene panel testing (MGPT) works among cancer patients who speak different languages and have diverse cultural and educational backgrounds. Genetic testing is a type of test that detects changes to the genes—the deoxyribonucleic acid (DNA) instructions that are passed on from the mother and father. The results of a genetic test can confirm whether the participant has a genetic disorder, which is a disease caused in whole or in part by changes to the genes. Genetic testing can also help determine a person’s chance of getting or passing on a genetic disorder. LCAM utilizes educational and clinical communication materials in order to offer patients streamlined access to multigene panel germline genetic testing through standardized education and test ordering by their oncologist/surgeon followed by post-test genetic counseling. LCAM may help patients from diverse cultural and educational backgrounds have better access to genetic testing and feel satisfied with their experience.
Additional locations may be listed on ClinicalTrials.gov for NCT04751435.
Locations matching your search criteria
United States
New York
Brooklyn
Kings County HospitalStatus: Active
Contact: Jason Parker Gonsky
Phone: 718-245-2847
Jamaica
Jamaica HospitalStatus: Active
Contact: Rosa Nouvini
Phone: 212-987-1777
New York
Queens Cancer Center MBCCOPStatus: Active
Contact: Linda Bulone
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Jada Hamilton
Phone: 646-888-0049
Ralph Lauren Center for Cancer Care and PreventionStatus: Active
Contact: Jada Hamilton
Phone: 646-888-0049
PRIMARY OBJECTIVES:
I. Adapt existing mainstreaming model pre-test educational materials (brochure and video) and post-test clinical communication materials (clinic visit summary and family dissemination messaging) to confirm relevance to and comprehension by the diverse patient population.
II. Test effects of the linguistically and culturally appropriate mainstreaming (LCAM) intervention on patient decision-making, psychosocial, and behavioral responses compared to standard-of-care.
EXPLORATORY OBJECTIVES:
I. Evaluate how effects of genetic testing model on decision-making, psychosocial, and behavioral responses may vary based on moderating characteristics of patient race, ethnicity, language, sex, health literacy, genetic literacy, or medical mistrust.
II. Describe long-term engagement among patients receiving variant of uncertain significance (VUS) results and possible variation across genetic testing models.
OUTLINE:
PHASE 1 (ENDED DECEMBER 2023): Participants review a sample of educational materials about genetic testing and participate in a cognitive interview over 90 minutes.
PHASE 2: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care pre-test and post-test genetic counseling via telegenetics videoconferencing. Patients who choose to undergo MGPT undergo blood or saliva sample collection for genetic testing on study and receive post-test genetic counseling after results are received. Patients who receive a VUS result are contacted by study staff 1 year after the receipt of their results and may undergo an additional telegenetics consultation with the study genetic counselor.
ARM II: Patients receive LCAM educational materials about genetic testing and discuss testing with their provider. Patients who choose to undergo MGPT undergo blood or saliva sample collection for genetic testing on study and receive post-test genetic counseling via telegenetics with a literacy screener after results are received. Patients who receive a VUS result are contacted by study staff 1 year after the receipt of their results and may undergo an additional telegenetics consultation with the study genetic counselor.
After completion of study intervention, patients are followed up immediately and at 6 months.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJada Hamilton