Prospective Trial of a Linguistically and Culturally Appropriate Mainstreaming Model for Hereditary Cancer Multigene Panel Testing Among Diverse Cancer Patients - PROJECT SUMMARY
Efficient yet effective models for delivering genetic counseling and testing are sorely needed to meet
increasing demands for timely genetic risk information. Traditional germline genetic testing models, which
include in-depth genetic counseling both before and after testing, are time intensive and place substantial
demands on the limited genetic counselor workforce. A “mainstreaming” model, which allows for non-genetics
healthcare providers to order genetic testing without pre-test genetic counseling, with support from genetic
counselors at the time of result disclosure, has shown promise. Yet, past evaluations of mainstreaming models
have been hampered by serious limitations: Studies were restricted to the context of BRCA1/2 testing and do
not reflect the growing use of multigene panel testing (MGPT); rarely used rigorous experimental study designs
or evaluated theoretically-relevant decision-making, psychosocial, and communication outcomes; have not
capitalized on opportunities to improve post-test clinical and familial communication; and neither included nor
addressed informational needs of minority and medically underserved patients. We overcome these limitations
with the proposed study, the objective of which is to develop, test, and evaluate a linguistically and culturally
appropriate mainstreaming (LCAM) model for hereditary cancer MGPT among cancer patients diverse in
race/ethnicity, language, and education. We will first use formative research methods, including transcreation
and cognitive interviewing, to adapt existing pre-test educational materials and post-test clinical communication
materials for use among the diverse population treated at our community hospital partnering sites (Kings
County Hospital Center, Queens Cancer Center). Next, we will conduct an RCT involving English, Haitian
Creole, or Spanish-speaking patients diagnosed with breast, ovarian, pancreatic, or prostate cancer (N=500).
Patients will be randomized to obtain access to cancer MGPT through either: i) standard-of-care wherein in-
depth pre-test and post-test genetic counseling are provided via telegenetics (i.e., videoconferencing delivered
at the site clinic) with standard post-test clinical communication materials, or ii) LCAM intervention wherein
patients receive the adapted pre-test educational materials with testing ordered by their oncologist, followed by
post-test genetic counseling provided via telephone with adapted clinical communication materials. Patients
will complete assessments of decision-making, psychosocial, and behavioral outcomes at baseline, upon
deciding whether to have MGPT, and at 1-week and 6-months following receipt of their test results. Long-term
engagement among patients who receive a variant of uncertain significance (VUS) result will also be explored
one year after result receipt through uptake of an offer to discuss any changes in cancer risk or variant
reclassification and an additional assessment. This research has the potential to transform genetic counseling
and testing practice by promoting effective risk communication, decision making, and more equitable delivery
of genomic medicine to those at risk of hereditary cancer syndromes.
