Akademska digitalna zbirka SLovenije - logo
E-viri
Recenzirano Odprti dostop
  • Randomized Noninferiority T...
    SCHWARTZ, Marc D; VALDIMARSDOTTIR, Heiddis B; MCKINNON, Wendy; GARBER, Judy; MCCORMICK, Shelley; KINNEY, Anita Y; LUTA, George; KELLEHER, Sarah; LEVENTHAL, Kara-Grace; VEGELLA, Patti; ANGIE TONG; LESLEY KING; PESHKIN, Beth N; MANDELBLATT, Jeanne; NUSBAUM, Rachel; HUANG, An-Tsun; YAOJEN CHANG; GRAVES, Kristi; ISAACS, Claudine; WOOD, Marie

    Journal of clinical oncology, 03/2014, Letnik: 32, Številka: 7
    Journal Article

    Although guidelines recommend in-person counseling before BRCA1/BRCA2 gene testing, genetic counseling is increasingly offered by telephone. As genomic testing becomes more common, evaluating alternative delivery approaches becomes increasingly salient. We tested whether telephone delivery of BRCA1/2 genetic counseling was noninferior to in-person delivery. Participants (women age 21 to 85 years who did not have newly diagnosed or metastatic cancer and lived within a study site catchment area) were randomly assigned to usual care (UC; n = 334) or telephone counseling (TC; n = 335). UC participants received in-person pre- and post-test counseling; TC participants completed all counseling by telephone. Primary outcomes were knowledge, satisfaction, decision conflict, distress, and quality of life; secondary outcomes were equivalence of BRCA1/2 test uptake and costs of delivering TC versus UC. TC was noninferior to UC on all primary outcomes. At 2 weeks after pretest counseling, knowledge (d = 0.03; lower bound of 97.5% CI, -0.61), perceived stress (d = -0.12; upper bound of 97.5% CI, 0.21), and satisfaction (d = -0.16; lower bound of 97.5% CI, -0.70) had group differences and confidence intervals that did not cross their 1-point noninferiority limits. Decision conflict (d = 1.1; upper bound of 97.5% CI, 3.3) and cancer distress (d = -1.6; upper bound of 97.5% CI, 0.27) did not cross their 4-point noninferiority limit. Results were comparable at 3 months. TC was not equivalent to UC on BRCA1/2 test uptake (UC, 90.1%; TC, 84.2%). TC yielded cost savings of $114 per patient. Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs.