Randomized Noninferiority Trial of Telephone vs In-Person Disclosure of Germline Cancer Genetic Test Results
| Autor: | Cassandra Gulden, Kristin Mattie, Terra Lucas, Jill Stopfer, Jessica Stoll, Danielle McKenna, Olufunmilayo I. Olopade, Sarah M. Nielsen, Linda Patrick-Miller, Christina Rybak, Kim Rainey, Xinxin Shirley Yao, Rachelle Chambers, Jacquelyn Powers, Brian L. Egleston, Andrea Forman, Angela R. Bradbury, Susan M. Domchek, Christina Seelaus, Jessica M. Long, Michelle Savage, Mary B. Daly, Rikki Gaber, Janice Horte, Pamela S. Ganschow, Susan Montgomery, Dominique Fetzer, Shreshtha Madaan, Dana F Clark, Generosa Grana, Amanda Brandt, Michael J. Hall |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Adult Male Cancer Research medicine.medical_specialty Genetic counseling Genetic Counseling Disclosure 030105 genetics & heredity law.invention Interviews as Topic 03 medical and health sciences 0302 clinical medicine Cognition Randomized controlled trial law Internal medicine medicine Biomarkers Tumor Humans Genetic Predisposition to Disease Genetic Testing Genetic testing medicine.diagnostic_test business.industry Random assignment Articles Middle Aged Neoplasms Germ Cell and Embryonal Confidence interval Genetic Testing for Cancer Risk Telephone Distress Affect Oncology 030220 oncology & carcinogenesis Anxiety Female medicine.symptom business |
| Zdroj: | Journal of the National Cancer Institute. 110(9) |
| ISSN: | 1460-2105 0173-6345 |
| Popis: | 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 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. 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 of multigene 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. |
| Databáze: | OpenAIRE |
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