J Natl Cancer Inst. 2018 Feb 27. doi: 10.1093/jnci/djy015. [Epub ahead of print]
Randomized Noninferiority Trial of Telephone vs In-Person Disclosure of Germline Cancer Genetic Test Results.
Bradbury AR1, Patrick-Miller LJ2, Egleston BL3, Hall MJ3, Domchek SM1, Daly MB3, Ganschow P4, Grana G5, Olopade OI2, Fetzer D1, Brandt A1, Chambers R2, Clark DF5, Forman A3, Gaber R4, Gulden C2, Horte J5, Long JM1, Lucas T4, Madaan S2, Mattie K5, McKenna D1, Montgomery S3, Nielsen S2, Powers J1, Rainey K3, Rybak C3, Savage M3, Seelaus C4, Stoll J2, Stopfer JE1, Yao XS5.
Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone disclosure (TD) of genetic test results with usual care, in-person disclosure (IPD) after tiered-binned in-person pretest counseling. Primary noninferiority outcomes included change in knowledge, state anxiety, and general anxiety. Secondary outcomes included cancer-specific distress, depression, uncertainty, satisfaction, and screening and risk-reducing surgery intentions. To declare noninferiority, we calculated the 98.3% one-sided confidence interval of the standardized effect; t tests were used for secondary subgroup analyses. Only noninferiority tests were one-sided, others were two-sided.