Randomized noninferiority trial of telephone vs in-person disclosure of germline cancer genetic test results

Angela R. Bradbury*, Linda J. Patrick-Miller, Brian L. Egleston, Michael J. Hall, Susan M. Domchek, Mary B. Daly, Pamela Ganschow, Generosa Grana, Olufunmilayo I. Olopade, Dominique Fetzer, Amanda Brandt, Rachelle Chambers, Dana F. Clark, Andrea Forman, Rikki Gaber, Cassandra Gulden, Janice Horte, Jessica M. Long, Terra Lucas, Shreshtha MadaanKristin Mattie, Danielle McKenna, Susan Montgomery, Sarah Nielsen, Jacquelyn Powers, Kim Rainey, Christina Rybak, Michelle Savage, Christina Seelaus, Jessica Stoll, Jill E. Stopfer, Xinxin Shirley Yao

*Corresponding author for this work

Research output: Contribution to journalArticle

12 Scopus citations

Abstract

Background: Germline genetic testing is standard practice in oncology. Outcomes of telephone disclosure of a wide range of cancer genetic test results, including multigene panel testing (MGPT) are unknown. Methods: 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 tieredbinned 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 riskreducing 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. Results: A total of 1178 patients enrolled in the study. Two hundred eight (17.7%) participants declined random assignment due to a preference for in-person disclosure; 473 participants were randomly assigned to TD and 497 to IPD; 291 (30.0%) had MGPT. TD was noninferior to IPD for general and state anxiety and all secondary outcomes immediately postdisclosure. TD did not meet the noninferiority threshold for knowledge in the primary analysis, but it did meet the threshold in the multiple imputation analysis. In secondary analyses, there were no statistically significant differences between arms in screening and risk-reducing surgery intentions, and no statistically significant differences in outcomes by arm among those who had MGPT. In subgroup analyses, patients with a positive result had statistically significantly greater decreases in general anxiety with telephone disclosure (TD 0.37 vs IPD 0.87, P .02). Conclusions: Even in the era ofmultigene panel testing, these data suggest that telephone disclosure of cancer genetic test results is as an alternative to in-person disclosure for interested patients after in-person pretest counseling with a genetic counselor.

Original languageEnglish (US)
Pages (from-to)985-993
Number of pages9
JournalJournal of the National Cancer Institute
Volume110
Issue number9
DOIs
StatePublished - Sep 1 2018
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Bradbury, A. R., Patrick-Miller, L. J., Egleston, B. L., Hall, M. J., Domchek, S. M., Daly, M. B., Ganschow, P., Grana, G., Olopade, O. I., Fetzer, D., Brandt, A., Chambers, R., Clark, D. F., Forman, A., Gaber, R., Gulden, C., Horte, J., Long, J. M., Lucas, T., ... Yao, X. S. (2018). Randomized noninferiority trial of telephone vs in-person disclosure of germline cancer genetic test results. Journal of the National Cancer Institute, 110(9), 985-993. https://doi.org/10.1093/jnci/djy015