The use of contralateral prophylactic mastectomy (CPM) in the United States among patients with unilateral invasive breast cancer has increased by 150% from 1993 to 2003 with no evidence of a plateau effect. The rising incidence of CPM among patients with sporadic breast cancer for whom there is no established psychosocial or clinical benefit or cost data is a critical area of public health concern. The objectives of this application are to evaluate the clinical benefits, risks and cost of CPM and to prospectively evaluate the decision making process leading to CPM among women with sporadic breast cancer. Thus the application is highly responsive to the NCI's program announcement that pertains both to enhancing the role of communication in improving cancer care and cancer survivorship. We will accomplish our objectives through the following two specific aims: 1a) Assess the association between CPM and disease-free survival (defined as contralateral breast cancer, distant recurrence and breast cancer mortality), 1b) Assess the health care resource utilization associated with CPM, which will include the surgical procedure, management of surgical complications and subsequent breast reconstruction and 2) Prospectively examine the psychosocial characteristics and decision-making process of women considering CPM. For aim 1, we will utilize the Breast Cancer Management System (BCMS) database of The University of Texas M. D. Anderson Cancer Center (MDACC), which has detailed patient and clinical information for patients with early stage unilateral invasive breast cancer. For the second aim, patients with sporadic early stage unilateral invasive breast cancer seen at the MDACC and their providers will be asked to participate in recorded consultation sessions. Both quantitative and qualitative methods will be used to assess clinical and psychosocial factors that are related to the decision to have CPM. We hypothesize that CPM will marginally improve disease-free survival, add substantial costs to the health care system and that patients with more cancer-related distress will be more likely to consider CPM. The findings from this study will form the basis for future research (e.g., intervention and/or observational studies) in this area that may be expanded to include multiple institutions. The proposed study is innovative because there are no studies to date that have prospectively evaluated the psychosocial factors that contribute to the decision-making process leading to CPM among patients with sporadic breast cancer. This research is important because of the rising incidence of CPM and the exposure of an increasing number of women to aggressive surgical management without established psychosocial or clinical benefit. The long-term impact of the proposed research is significant because it will lead to the development of an evidence-based clinical educational intervention that will enable patients with sporadic breast cancer and their providers to make more informed decisions regarding CPM and improve the quality of life of breast cancer survivors.

PUBLIC HEALTH RELEVANCE: The rising incidence of contralateral prophylactic mastectomy among patients with sporadic breast cancer for whom there is no established psychosocial or clinical benefit or cost data is a critical area of public health concern. The proposed study will evaluate the clinical benefits, risks and cost of CPM and prospectively evaluate the decision making process leading to CPM among women with sporadic breast cancer. The results of the study will be used to develop a clinical educational instrument that will enable patients with sporadic breast cancer and their providers to make more informed decisions regarding CPM which will serve to improve the quality of life of breast cancer survivors.

R21CA149803

2010-09-15

2012-08-31