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F3‐03‐03: Disclosure of amyloid status in the a4 trial
Author(s) -
Sperling Reisa A.,
Karlawish Jason,
Grill Joshua D.,
Burns Jeffrey M.,
Sultzer David,
Johnson Keith A.,
Aisen Paul S.
Publication year - 2015
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2015.07.232
Subject(s) - amyloid (mycology) , medicine , anxiety , cognition , clinical psychology , psychology , psychiatry , pathology
Background:Disclosure of predictive genetic test results has traditionally been provided in-person to optimize understanding, psychosocial support, communication to relatives and adoption of risk reduction behaviors. In the API APOE4 Trial, homozygotes and a random sample of non-homozygotes will be invited to trial sites for screening and disclosure of APOE genotype. Limited availability of genetic counselors with expertise in AD presents a potential barrier to implementation of the trial. Telephone and real-time videoconferencing (RTVC) are two methods for remote communication which can provide access to genetic providers in medical systems without genetic counselors. The relative advantages of RTVC over telephone have not been evaluated in a randomized trial. Methods: Ongoing and completed National Cancer Institute (NCI) funded studies evaluating telephone and RTVC as alternative delivery modalities for genetic counseling in BRCA1/2 testing have informed a randomized evaluation of telephone versus RTVC disclosure of APOE genotype in the API APOE4 Trial Genetic Testing and Counseling Program (GTCP). Results:Telephone counseling has been found to be equivalent to in-person counseling for BRCA1/2 testing in two NCI funded randomized studies (Schwartz et al, Kinney et al) published in 2014. Communication protocols and results from an ongoing NCI funded multi-site randomized study evaluating telephone disclosure of genetic test results for a broader range of cancer susceptibility test results and powered to evaluate differences in outcomes among patients receiving a positive result have informed telephone delivery protocols and outcomes in the API APOE4 GTCP. In a separate NCI funded study, RTVC has been found to be feasible, valued by patients and associated with increased in knowledge and favorable psychosocial outcomes for cancer susceptibility genetic testing. Similarly, RTVC protocols for genetic counseling have been adapted for AD and the RTVC comparison arm in the API APOE4GTCP. Conclusions:The API APOE GTCP randomized evaluation of two remote genetic counseling models will support enrollment into the API APOE4 Trial and provide protocols for clearly and safely communicating sensitive genetic information. Results from the GTCP will provide crucial information regarding the implementation and delivery of APOE genotype results relevant to clinical practice and precision medicine.