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Original Article |
1 Research and Evaluation Department, Kaiser Permanente Southern California, Pasadena, California 91188, USA
2 Division of Public Health Sciences, Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157, USA
3 Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care, Boston, Massachusetts 02215, USA
4 Division of Research, Kaiser Permanente Northern California, Oakland, California 94612, USA
5 HealthPartners Research Foundation, Minneapolis, Minnesota 55440, USA
6 Center for Health Studies, Group Health, Seattle, Washington 98103, USA
7 Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California 90033, USA
8 Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon 97227, USA
9 Division of General Internal Medicine, University of Washington, Seattle, Washington 98104, USA
10 Center for Community-Based Research, Dana Farber Cancer Institute, Boston, Massachusetts 02115, USA
Correspondence: Address correspondence and reprint requests to: Ann M. Geiger, PhD; E-mail: ageiger{at}wfubmc.edu
| ABSTRACT |
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Methods: To examine long-term quality of life after bilateral prophylactic mastectomy, we mailed surveys to 195 women who had the procedure from 1979 to 1999 and to a random sample of 117 women at increased breast cancer risk who did not have the procedure. Measures were modeled on or drawn directly from validated instruments designed to assess quality of life, body image, sexuality, breast cancer concerns, depression, health perception, and demographic characteristics. We used logistic regression to examine associations between quality of life and other domains.
Results: The response rate was 58%, with 106 women with and 62 women without prophylactic mastectomy returning complete surveys. Among women who underwent bilateral prophylactic mastectomy, 84% were satisfied with their decision to have the procedure; 61% reported high contentment with quality of life compared with an identical 61% of women who did not have the procedure (P = 1.0). Among all subjects, diminished contentment with quality of life was not associated with bilateral prophylactic mastectomy but with dissatisfaction with sex life (adjusted ratio [OR] = 2.5, 95% confidence interval [CI] = 1.06.2), possible depression (CES-D > 16, OR = 4.9, CI = 2.011.8), and poor or fair general health perception (OR = 8.3, 95% CI = 2.429.0).
Conclusions: The majority of women reported satisfaction with bilateral prophylactic mastectomy and experienced psychosocial outcomes similar to women with similarly elevated breast cancer risk who did not undergo prophylactic mastectomy. Bilateral prophylactic mastectomy appears to neither positively nor negatively impact long-term psychosocial outcomes.
Key Words: Breast cancer Prophylaxis Mastectomy Quality of life Satisfaction
| INTRODUCTION |
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In a previous study,6 we found a reduction in breast cancer incidence after bilateral prophylactic mastectomy in women at elevated breast cancer risk compared with women with similar risk who did not undergo the procedure (hazard ratio = 0.005, 95% confidence interval [CI] = 0.0010.044). In the present study, we surveyed women from the same cohort, both those who had and those who had not undergone bilateral prophylactic mastectomy. We sought to determine the extent to which womens quality of life was affected by bilateral prophylactic mastectomy and to examine psychosocial factors associated with diminished contentment with quality of life in women at elevated breast cancer risk.
| METHODS |
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Subjects
Subjects for this study were drawn from our earlier study of bilateral prophylactic mastectomy efficacy.6 Eligible women were between the ages of 18 and 80 years, were members of the participating healthcare delivery systems, had at least one qualifying breast cancer risk factor noted in their medical record, and had no personal history of breast cancer. Qualifying breast cancer risk factors included a family history of breast cancer, a personal history of atypical hyperplasia, one or more benign breast biopsies, lobular carcinoma in situ, microcalcifications, or ovarian cancer. The earlier study used a case-cohort design in which all women who underwent bilateral subcutaneous or more extensive prophylactic mastectomies from 1979 to 1999 were included, along with a random sample of women at elevated breast cancer risk but with no prophylactic mastectomies, frequency-matched within each healthcare delivery system by year of birth (up to 1944 or 1945 and after). We included both groups of women in this study.
Women were identified and classified from automated enrollment, hospitalization, ambulatory care, and cancer registry data. Eligibility was confirmed by medical record review, including verification that the bilateral mastectomy was performed for prophylactic reasons. Deceased women were excluded after being identified from medical record review and automated health system data and state mortality records. At three healthcare delivery systems, Institutional Review Boards required that women also be excluded if their physicians declined to give approval for their recruitment (Table 1
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Survey Measures
Based on published literature and the results of two focus groups conducted at one delivery system, we selected domains likely to be important to women and to be positively or negatively impacted by bilateral prophylactic mastectomy. The selected survey domains included: contentment with current quality of life, experience of breast cancer thoughts, body image, sexual satisfaction, depression, health perception, and demographics. We reviewed existing measures to identify batteries that would be pertinent to our participants. However, because measurement of these domains is not standardized and existing measures often focus on women diagnosed with a specific medical condition like breast cancer, we found many measures required adaptation before use in our study. All questions were in closed form with Likert scales and asked women to rate all items with reference to the past 30 days. To maximize participation we sought to minimize respondent burden by limiting the final survey to seven pages with an estimated completion time of 1015 minutes.
We assessed current contentment with quality of life and sexual satisfaction using a single item each as used in the Functional Assessment of Cancer Therapy-Breast Cancer scale16 (from the Functional Well-Being and Additional Concerns subscales, respectively). A single item each for satisfaction with prophylactic mastectomy and breast cancer concern was developed based on questions used successfully in an evaluation of a breast cancer support program.17 Items for avoiding thoughts about breast cancer and experiencing intrusive breast cancer thoughts were developed using questions, five and two, respectively, modeled on the Revised Impact of Events scale.18 Body image was assessed using four questions modeled on Hopwood et al.19 Depressive symptoms were measured using the complete Center for Epidemiologic Studies-Depression (CES-D) scale.20 Health perception was measured using a single item from the Medical Outcomes Study Short Form-36.21 Demographics questions were drawn from the Behavioral Risk Factor Surveillance System.22
Our draft survey underwent several rounds of review and revision based on study team and outside psychometric review for face validity and content and format. Pilot testing of the survey draft was conducted with 11 women from one delivery system using cognitive interviewing techniques23,24 to identify issues related to content validity and discomfort with domains. Women participating in the pilot study were overwhelmingly unwilling to answer a longer and more detailed battery of sexual satisfaction questions and to complete the full Revised Impact of Events scale, thus necessitating additional modifications. Women who participated in focus groups or completed cognitive interviews were not surveyed. The final survey is available at http://crn.cancer.gov/areas/survivorship/mastectomy.html.
Statistical Analysis
Two-sided
2 tests were used to test for differences between women with and without bilateral prophylactic mastectomy, with P < 0.05 considered statistically significant. Before modeling we performed stratified analyses to identify confounding and interaction effects; confounders were incorporated into the final model and no interaction effects were found. Logistic regression was used to calculate odds ratios (OR) and 95% CI. The final model included all variables identified as confounders or in which a confidence interval excluded the null value. Single-item measures were dichotomized as shown in Tables 2
and 3
to ensure adequate cell sizes in the model. Examining the four body image items revealed two clusters of two items each so one item was selected to represent each cluster. For avoiding thoughts about breast cancer and experiencing intrusive breast cancer thoughts, we totaled scored responses as done in the original instrument18 and present the results in tertiles. The CES-D20 was scored as originally designed. All analyses were performed with SAS software v8.2 (SAS Institute, Cary, NC).
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| RESULTS |
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Comparing Women With and Without Bilateral Prophylactic Mastectomy
Women who underwent bilateral prophylactic mastectomy were somewhat younger and more likely to be white than women who had not undergone the procedure (Table 1
). Women who underwent bilateral prophylactic mastectomy were more likely to have a family history of breast cancer than women who had not undergone the procedure (P < 0.001). Women with and without prophylactic mastectomy were similar in terms of education and body mass index. The majority [89 (84%)] of women who underwent prophylactic mastectomy also underwent breast reconstruction.
A majority of women (84%) reported satisfaction with their decision to undergo bilateral prophylactic mastectomy (Table 3
). Over half of all women reported being very much or quite a bit contented with their quality of life, regardless of whether they had undergone bilateral prophylactic mastectomy (61% among both groups). Concern about breast cancer was reported by about 60% of women who had and had not undergone prophylactic mastectomy. No statistically significant differences were found between the groups for these and other psychosocial factors, including self-consciousness and satisfaction with appearance, satisfaction with sex life, possible depression defined as a CES-D score greater than 16, and general health perception. Psychosocial outcomes did not vary between women who underwent bilateral prophylactic mastectomy who did and did not have breast reconstruction (data not shown).
Factors Associated with Being Less Content with Quality of Life Among All Respondents
Diminished contentment with quality of life was not associated with bilateral prophylactic mastectomy (adjusted odds ratio [OR] = 0.8, 95% CI = 0.32.0, Table 4
). Among all women, regardless of whether they underwent bilateral prophylactic mastectomy, diminished contentment with quality of life was associated with dissatisfaction with sex life (OR = 2.5, 95% CI = 1.06.2), possible depression (OR = 4.9, 95% CI = 2.011.8), and less than very good or excellent health perception (good OR = 2.9, 95% CI = 1.17.3; poor or fair OR = 8.3, 95% CI = 2.429.0). Diminished contentment had borderline statistically significant associations with dissatisfaction with appearance when dressed (OR = 1.8, 95% CI = 0.84.5) and age 65 years and older (OR = 2.9, 95% CI = 0.99.3). Diminished contentment with quality of life was not associated with concern about breast cancer, experience of breast cancer thoughts, year of prophylactic mastectomy, or first medical record note of a breast cancer risk factor for women who had not undergone the procedure.
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| DISCUSSION |
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Our findings of a large percentage of women reporting satisfaction with bilateral prophylactic mastectomy are consistent with other reports. The four relevant previous studies found that the majority of women who had undergone bilateral prophylactic mastectomy were satisfied with their decision. Satisfaction was reported by 95% or more of women in three studies: (1) 14 women in referral center-based study,7 (2) several hundred women voluntarily registering in a national prophylactic mastectomy registry,8 and (3) 60 women in a community-based study.12 A larger study in a referral center reported that 70% of 572 women were satisfied with their procedure.9 While it is possible that women who are dissatisfied declined to participate in these studies, the available evidence suggests that most women will be satisfied with bilateral prophylactic mastectomy whether it is performed in a referral clinic or community setting.
To our knowledge our study is the first on bilateral prophylactic mastectomy to include both overall quality of life measures and a concurrent comparison group of women with increased breast cancer risk. Hatcher et al.11 compared similarly at-risk women with and without bilateral prophylactic mastectomy but did not assess overall quality of life. They reported postprocedure reductions in psychological morbidity and anxiety, with no change in body image or sexual functioning. Women who had undergone prophylactic mastectomy at a referral clinic in Manchester, United Kingdom, were found to have psychological distress and body image scores comparable to women who had undergone breast cancer risk assessment or mastectomy for breast cancer,10 but these comparison groups might not have had the same risk perception as women at increased risk for breast cancer who had undergone prophylactic mastectomy. In a study of women undergoing prophylactic mastectomy in the Province of Ontario, Canada, nearly 60% of women who had the procedure had higher Quality of Life Index scores than the general population. Lower quality of life among the study participants was associated with psychological distress and body image challenges,13 but in the absence of a comparison group these results cannot be attributed to prophylactic mastectomy. Based on womens retrospective recall of their status at the time of their procedure, Frost et al.9 found that over half of the women reported either no change or an improvement in emotional stability, body image, and sexual relationships. Global quality of life measures were not reported, nor was there a comparison group. Although these prior studies suggest that many women who undergo prophylactic mastectomy experience psychological distress and body image and sexuality challenges, the use of a concurrent comparison group in our study suggests that these negative consequences are just as common in women with increased breast cancer risk who do not undergo prophylactic mastectomy.
The extent to which prophylactic mastectomy may reduce concern about breast cancer remains unclear. In the study reported by Metcalf et al.,12,13 several women reported extreme breast cancer concern in the form of intrusive thoughts, but ultimately these concerns were not associated with quality of life once other factors were considered. While Frost et al.9 reported that 74% of women reported a decrease in breast cancer concern after bilateral prophylactic mastectomy, this was based on women retrospectively reporting their level of concern before their procedure. If, as documented by one study,27 womens retrospectively reported perception of their breast cancer risk before prophylactic mastectomy is exaggerated, reports of decreased concern may be due to recall bias. We found that concern about breast cancer exists in similar percentages among women with and without bilateral prophylactic mastectomy, but in the absence of a baseline measure, our study is unable to examine a reduction in concern as a result of the procedure.
This highlights an important limitation of our study, the cross-sectional assessment of quality of life. Without preprophylactic mastectomy assessment of psychosocial and other factors, we are unable to determine whether women who did and did not undergo mastectomy differed systematically before the procedures and the extent to which baseline differences might have influenced long-term psychosocial outcomes. In addition, we have no information on surveillance or chemoprevention in our comparison group, so we cannot examine the impact of these alternatives to prophylactic mastectomy on psychosocial outcomes. Similarly, because the majority of women in our study received prophylactic mastectomy before genetic testing became available, our results may not generalize to women carrying BRCA1 or BRCA2 mutations.
Another limitation was our response rate of 58.0%, driven in part by one of the Institutional Review Boards requiring active consent from subjects primary care physicians.28 When reported, response rates in the prior studies of prophylactic mastectomy ranged from 61.8% to 94.0%,911 with a response rate of 80.0% in the study most comparable to ours.12,13 In our study we found that respondents and nonrespondents were similar in their demographic characteristics.
A final important limitation in our study is differences in the prevalence of a medical record-documented family history of breast cancer between women with and without prophylactic mastectomy, raising the question of whether the two groups experienced similar levels of concern about breast cancer. If we assume that our comparison group of women without prophylactic mastectomy experienced a less acute sense of risk and that this lesser sense of risk is associated with reduced concern about breast cancer and increased quality of life, then one would expect this to bias our results toward finding a difference between women with and without prophylactic mastectomy. Thus, our finding that most women who underwent prophylactic mastectomy experienced a good quality of life comparable to women who did not have the procedure seems even more striking.
| CONCLUSION |
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| ACKNOWLEDGMENTS |
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| FOOTNOTES |
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Received for publication July 24, 2006. Accepted for publication July 26, 2006.
| REFERENCES |
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This article has been cited by other articles:
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A. Recht Contralateral Prophylactic Mastectomy: Caveat Emptor J. Clin. Oncol., March 20, 2009; 27(9): 1347 - 1349. [Full Text] [PDF] |
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L. R. Schover A Lesser Evil: Prophylactic Mastectomy for Women at High Risk for Breast Cancer J. Clin. Oncol., August 20, 2008; 26(24): 3918 - 3919. [Full Text] [PDF] |
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