دورية أكاديمية

Randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer.

التفاصيل البيبلوغرافية
العنوان: Randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer.
المؤلفون: Schwartz MD; Marc D. Schwartz, Beth N. Peshkin, Jeanne Mandelblatt, Rachel Nusum, An-Tsun Huang, Yaojen Chang, Kristi Graves, Claudine Isaacs, George Luta, Sarah Kelleher, Kara-Grace Leventhal, Patti Vegella, Angie Tong, and Lesley King, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC; Heiddis B. Valdimarsdottir, Mount Sinai School of Medicine, New York, NY; Marie Wood and Wendy McKinnon, Familial Cancer Program of the Vermont Cancer Center, University of Vermont College of Medicine, Burlington, VT; Judy Garber and Shelley McCormick, Dana-Farber Cancer Institute-Harvard Medical School, Boston, MA; and Anita Y. Kinney, University of Utah School of Medicine and Huntsman Cancer Institute, Salt Lake City, UT., Valdimarsdottir HB, Peshkin BN, Mandelblatt J, Nusbaum R, Huang AT, Chang Y, Graves K, Isaacs C, Wood M, McKinnon W, Garber J, McCormick S, Kinney AY, Luta G, Kelleher S, Leventhal KG, Vegella P, Tong A, King L
المصدر: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2014 Mar 01; Vol. 32 (7), pp. 618-26. Date of Electronic Publication: 2014 Jan 21.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology
Original Publication: New York, N.Y. : Grune & Stratton, c1983-
مواضيع طبية MeSH: Breast Neoplasms*/genetics , Breast Neoplasms*/prevention & control , Breast Neoplasms*/psychology , Breast Neoplasms*/therapy , Decision Making* , Genetic Testing* , Mutation* , Ovarian Neoplasms*/genetics , Ovarian Neoplasms*/prevention & control , Ovarian Neoplasms*/psychology , Ovarian Neoplasms*/therapy , Telephone*, Genetic Counseling/*economics , Genetic Counseling/*methods, Adult ; Aged ; Aged, 80 and over ; Conflict, Psychological ; Cost-Benefit Analysis ; Female ; Genes, BRCA1 ; Genes, BRCA2 ; Health Knowledge, Attitudes, Practice ; Humans ; Middle Aged ; Patient Satisfaction ; Quality of Life ; Stress, Psychological/etiology
مستخلص: Purpose: 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.
Patients and Methods: 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.
Results: 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.
Conclusion: Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs.
التعليقات: Comment in: J Clin Oncol. 2014 Mar 1;32(7):611-2. (PMID: 24449232)
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معلومات مُعتمدة: U01 CA152958 United States CA NCI NIH HHS; P30CA051008 United States CA NCI NIH HHS; P30 CA051008 United States CA NCI NIH HHS; R01CA108933 United States CA NCI NIH HHS; R01 CA108933 United States CA NCI NIH HHS
سلسلة جزيئية: ClinicalTrials.gov NCT00287898
تواريخ الأحداث: Date Created: 20140123 Date Completed: 20140421 Latest Revision: 20220409
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC3927731
DOI: 10.1200/JCO.2013.51.3226
PMID: 24449235
قاعدة البيانات: MEDLINE
الوصف
تدمد:1527-7755
DOI:10.1200/JCO.2013.51.3226