Behavioral and psychosocial effects of rapid genetic counseling and testing in newly diagnosed breast cancer patients: Design of a multicenter randomized clinical trial

BMC Cancer

Study Protocol

Senno Verhoef¹  Frans BL Hogervorst¹  Rob B van der Luijt²  Margreet GEM Ausems²  Daniela EE Hahn³  Eveline MA Bleiker⁴  Neil K Aaronson⁴  Marijke R Wevers⁵  Richard van Hillegersberg⁶  Emiel JTh Rutgers⁷  Heiddis B Valdimarsdottir⁸ 

[1] Division of Diagnostic Oncology, The Netherlands Cancer Institute, PO Box 90203, 1006, Amsterdam, BE, The Netherlands;Division of Medical Genetics, University Medical Center Utrecht, PO Box 85090, 3508, Utrecht, AB, The Netherlands;Division of Medical Oncology, The Netherlands Cancer Institute, PO Box 90203, 1006, Amsterdam, BE, The Netherlands;Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, PO Box 90203, 1006, Amsterdam, BE, The Netherlands;Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, PO Box 90203, 1006, Amsterdam, BE, The Netherlands;Division of Medical Genetics, University Medical Center Utrecht, PO Box 85090, 3508, Utrecht, AB, The Netherlands;Division of Surgery, University Medical Center Utrecht, PO Box 85500, 3508, Utrecht, GA, The Netherlands;Division of Surgical Oncology, The Netherlands Cancer Institute, PO Box 90203, 1006, Amsterdam, BE, The Netherlands;Oncological Sciences Department, Mount Sinai School of Medicine, Icahn Medical Institute, 1425 Madison Avenue, 10029, New York, NY, USA;

关键词: Breast Cancer;    Genetic Counseling;    Contralateral Breast Cancer;    Usual Care Group;    Contralateral Prophylactic Mastectomy;   

DOI  :  10.1186/1471-2407-11-6

 received in 2010-03-30, accepted in 2011-01-10,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundIt has been estimated that between 5% and 10% of women diagnosed with breast cancer have a hereditary form of the disease, primarily caused by a BRCA1 or BRCA2 gene mutation. Such women have an increased risk of developing a new primary breast and/or ovarian tumor, and may therefore opt for preventive surgery (e.g., bilateral mastectomy, oophorectomy). It is common practice to offer high-risk patients genetic counseling and DNA testing after their primary treatment, with genetic test results being available within 4-6 months. However, some non-commercial laboratories can currently generate test results within 3 to 6 weeks, and thus make it possible to provide rapid genetic counseling and testing (RGCT) prior to primary treatment. The aim of this study is to determine the effect of RGCT on treatment decisions and on psychosocial health.Methods/DesignIn this randomized controlled trial, 255 newly diagnosed breast cancer patients with at least a 10% risk of carrying a BRCA gene mutation are being recruited from 12 hospitals in the Netherlands. Participants are randomized in a 2:1 ratio to either a RGCT intervention group (the offer of RGCT directly following diagnosis with tests results available before surgical treatment) or to a usual care control group. The primary behavioral outcome is the uptake of direct bilateral mastectomy or delayed prophylactic contralateral mastectomy. Psychosocial outcomes include cancer risk perception, cancer-related worry and distress, health-related quality of life, decisional satisfaction and the perceived need for and use of additional decisional counseling and psychosocial support. Data are collected via medical chart audits and self-report questionnaires administered prior to randomization, and at 6 month and at 12 month follow-up.DiscussionThis trial will provide essential information on the impact of RGCT on the choice of primary surgical treatment among women with breast cancer with an increased risk of hereditary cancer. This study will also provide data on the psychosocial consequences of RGCT and of risk-reducing behavior.Trial registrationThe study is registered at the Netherlands Trial Register (NTR1493) and ClinicalTrials.gov (NCT00783822).

【 授权许可】

Unknown   
© Wevers et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.