Patient-oriented Outcomes of Prophylactic Mastectomy

Background

Women at increased risk for breast cancer face a difficult decision about the role of prophylactic mastectomy (PM) in their effort to prevent breast cancer. While evidence suggests a substantial reduction in breast cancer risk occurs after prophylactic mastectomy, its effect on other patient-oriented outcomes is unclear. This is particularly true for women undergoing prophylactic mastectomy after breast cancer occurred in the contralateral breast. This study sought to address this knowledge gap by gathering information on patient-oriented outcomes from women identified for a related CRN study of the efficacy of prophylactic mastectomy in six HMO community-based populations across the United States. The PM Outcomes study included women with bilateral prophylactic mastectomy done for a family history of breast cancer or a personal history of benign breast disease, as well as women with breast cancer who underwent unilateral prophylactic mastectomy of the contralateral breast.

Study Aims

1. Describe the subjective experience of women with a family history of breast cancer or benign breast disease who underwent bilateral prophylactic mastectomy and women with a personal history of breast cancer who underwent unilateral prophylactic mastectomy. In particular, we were interested in whether women were willing to recommend prophylactic mastectomy to others in similar circumstances and whether the willingness to recommend prophylactic mastectomy to similar women varied by:  
   
   
• Indication for and type of procedure (family history or benign breast disease=bilateral; personal history=unilateral).
• Time since prophylactic mastectomy.
• Major complications within one year of prophylactic mastectomy.
• Reconstruction after prophylactic mastectomy.
• Demographic characteristics, such as age, race/ethnicity, education, and geographic location.

2. Compare breast cancer risk-related stress, body image, sexual activity and satisfaction, and health perception of women among women who underwent prophylactic mastectomy compared with similar women who did not have this procedure. Comparisons of women with prophylactic mastectomy were made within two groups: (a) women with a family history of breast cancer or personal history of benign breast disease ("bilateral PM-eligible"), and (b) women with a personal history of breast cancer ("unilateral PM-eligible"). These comparisons considered important potential co-variates such as: co-morbid conditions, age, race/ethnicity, education and geographic location.

Methods

This study used focus groups and a mailed survey to gather patient-oriented outcomes from women identified for the prophylactic mastectomy (PM) efficacy study. To be eligible, women must have been members at one of six HMOs at some time during the period 1979 to 1998. Focus groups of women were conducted to ensure the survey incorporates the outcomes most important to women undergoing PM and to inform development of questions regarding women's willingness to recommend PM to similar women. This process also netted a wealth of qualitative information relating to how women make the decision to have a PM, information which is being summarized and published.

A self-administered survey of all women assessed breast cancer risk-related stress; body image; sexual activity and satisfaction; and health perception. Within each group of subjects comparisons were made between of women who had PM to those who had not. Additionally, women with PM were asked about their willingness to recommend PM to similar women.

Significance

Unlike previous studies, this study provided patient-oriented outcomes data for a large number of women undergoing both unilateral and bilateral PM from well-defined populations with geographic and ethnic diversity. This has resulted in improved generalizability and also decreased the influence of bias due to undetected patterns of selection of women for PM in academic or specialty clinic populations. We utilized standardized instruments whenever possible and included an appropriate comparison group for both bilateral and unilateral PM. Also, our sample size was adequate to control for potential confounders and to assess effect modification.

The results of this study will markedly improve the quality and quantity of information women at increased risk for breast cancer and their clinicians have available when evaluating PM as a preventive option.

Project Status

This project was funded as an investigator-initiated R01, and is closely affiliated with the CRN. The principal investigator is Ann Geiger, PhD, formerly from Kaiser Permanente Southern California, now at Wake Forest University.  The project bibliography as of July 2006 is furnished here, along with a link to the self-administered survey used in the study.

Project Publications

Geiger AM, Nekhlyudov L, Herrinton LJ, Rolnick S, Greene SM, West CN, Harris E, Elmore JG, Altschuler A, Fletcher SW, Emmons K. Quality of life after bilateral prophylactic mastectomy. Ann Surg Oncol (in press).

Geiger AM, West CN, Nekhlyudov LN, Herrinton LJ, Liu AI, Altschuler A, Rolnick SJ, Harris EL, Greene SM, Elmore JG, Emmons K, Fletcher SW. Contentment with quality of life among breast cancer survivors with and without contralateral prophylactic mastectomy. J Clin Oncol 2006;24:1350-56.

Greene SM, Geiger AM, Harris E, Altschuler A, Nekhlyudov L, Barton M, Rolnick SJ, Fletcher S. Impact of IRB requirements on a multi-site Cancer Research Network study. Ann Epidemiol 2006;16:275-78.

Nekhlyudov L, Bower M, Herrinton L, Altschuler A, Greene S. Rolnick C, Elmore J, Harris E, Liu IA, Emmons KM, Fletcher SW, Geiger AM. Women’s decision-making roles regarding contralateral prophylactic mastectomy. J Natl Cancer Inst Monogr 2005;35:55-60.

Prophylactic Mastectomy Outcomes Study Survey [Word] [PDF]

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