||5R01CA160847-02 Interpret this number
||University Of Pennsylvania
||Communicating Genetic Test Results By Telephone: a Randomized Trial
DESCRIPTION (provided by applicant): Basic science advances in genomics have provided great promise for improving human health and reducing the burden of cancer in the United States, fueling the rapidly growing field of personalized medicine. Yet, translating gene discoveries into responsible and effective applications that benefit the health of individuals and populations presents many challenges. Genetic screening for cancer susceptibility is one application of "personalized medicine", which has become standard evidence-based practice in cancer prevention. Given the increasing demand for genetic testing and the desire to disseminate services broadly to optimize population health benefits, the current delivery model for genetic testing in oncology presents barriers to widespread dissemination. Telephone delivery of genetic services is one innovative and efficient delivery model that has the potential to expand genetic services to diverse clinical systems and address the increasing number of genetic applications entering clinical practice. While there are potential advantages to telephone delivery of services, there are also potential disadvantages, particularly in the setting of a positive test result. The overall objective of this proposal is to evaluate the psychological, behavioral and economic outcomes (i.e. risks and benefits) of an efficient delivery model of genetic services, telephone communication, as compared to in- person communication of genetic test results. BRCA1/2 and Lynch syndrome genetic testing are two of the most advanced evidence-based genomic applications available in clinical medicine. Thus, they provide optimal genetic applications for translational genomic research focused on dissemination and delivery of genetic services. We propose a multi-center randomized trial of telephone communication as compared to in- person communication of genetic test results in sociodemographically diverse clinical populations. As the promise of genomic advances ultimately depends upon change in health and risk behavior, our study is guided by the Self-Regulation Theory of Health Behavior. In Aim 1, we will evaluate the efficacy of our telephone disclosure protocol to provide equal short-term outcomes (knowledge and perceptions of genetic disease, psychological distress, and satisfaction with genetic services, behavioral intentions and patient & system costs) to the current standard-of-care, in-person communication of genetic test results. In Aim 2, we will compare 12 month outcomes (psychological adjustment and performance of health behaviors) between the two delivery arms. In Aim 3, we will explore patient factors (e.g. test result, ethnicity, and access barriers) which could identify subgroups fr which telephone communication might be particularly harmful or particularly useful. We expect this translational genomic research to inform evidence based practice guidelines and potentially change the paradigm of delivery of genetic services within, and beyond oncology. Given the rising number of available genetic tests, this research has the potential to impact a significant and growing community of patients and their providers seeking genetic risk information to improve their health.