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Contentment With Quality of Life Among Breast Cancer Survivors With and Without Contralateral Prophylactic Mastectomy

Ann M. Geiger, Carmen N. West, Larissa Nekhlyudov, Lisa J. Herrinton, In-Liu A. Liu, Andrea Altschuler, Sharon J. Rolnick, Emily L. Harris, Sarah M. Greene, Joann G. Elmore, Karen M. Emmons, Suzanne W. Fletcher

From the Research and Evaluation Department, Kaiser Permanente Southern California, Pasadena; Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles; Division of Research, Kaiser Permanente Northern California, Oakland, CA; Department of Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC; Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care; Center for Community-Based Research, Dana-Farber Cancer Institute, Boston, MA; HealthPartners Research Foundation, Minneapolis, MN; Center for Health Research, Kaiser Permanente Northwest, Portland, OR; Center for Health Studies, Group Health Cooperative; Division of General Internal Medicine, University of Washington, Seattle, WA

Address reprint requests to Ann M. Geiger, PhD, Department of Social Sciences and Health Policy, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, 27157; e-mail: ageiger{at}wfubmc.edu

	ABSTRACT

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PURPOSE: To understand psychosocial outcomes after prophylactic removal of the contralateral breast in women with unilateral breast cancer.

METHODS: We mailed surveys to women with contralateral prophylactic mastectomy after breast cancer diagnosis between 1979 and 1999 at six health care delivery systems, and to a smaller random sample of women with breast cancer without the procedure. Measures were modeled on instruments developed to assess contentment with quality of life, body image, sexual satisfaction, breast cancer concern, depression, and health perception. We examined associations between quality of life and the other domains using logistic regression.

RESULTS: The response rate was 72.6%. Among 519 women who underwent contralateral prophylactic mastectomy, 86.5% were satisfied with their decision; 76.3% reported high contentment with quality of life compared with 75.4% of 61 women who did not undergo the procedure (P = .88). Among all case subjects, less contentment with quality of life was not associated with contralateral prophylactic mastectomy or demographic characteristics, but was associated with poor or fair general health perception (odds ratio [OR], 7.0; 95% CI, 3.4 to 14.1); possible depression (OR, 5.4; 95% CI, 3.1 to 9.2); dissatisfaction with appearance when dressed (OR, 3.5; 95% CI, 2.0 to 6.0); self-consciousness about appearance (OR, 2.0; 95% CI, 1.1 to 3.7); and avoiding thoughts about breast cancer (modest: OR, 2.2; 95% CI, 1.1 to 4.5; highest: OR, 1.7; 95% CI, 0.9 to 3.2).

CONCLUSION: Most women undergoing contralateral prophylactic mastectomy report satisfaction with their decision and experience psychosocial outcomes similar to breast cancer survivors without the procedure.

	INTRODUCTION

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Women with unilateral breast cancer have an approximately three to five times higher risk of developing contralateral breast cancer than women without breast cancer; and women with a family history of breast cancer have an even higher risk.^1,2 Thus, prophylactic mastectomy of the contralateral breast may be a desirable treatment and prevention approach for some women with unilateral breast cancer. Three studies have reported that contralateral prophylactic mastectomy substantially reduces the risk of contralateral breast cancer^3-6 and two studies suggested improvements in breast cancer survival.^3,5 Although most women are satisfied with their procedure,^7,8 information on other psychosocial outcomes is limited and not available for women cared for in community practices. Multiple studies have reported generally positive psychosocial outcomes after bilateral prophylactic mastectomy,^9-15 but it is unclear how generalizable these results are to women with contralateral prophylactic mastectomy.

In a study of contralateral prophylactic mastectomy efficacy,³ we found a reduction in both contralateral breast cancer (hazard ratio, 0.03; 95% CI, 0.006 to 0.13) and breast cancer mortality (hazard ratio, 0.57; 95% CI, 0.45 to 1.72). In the present study, we surveyed women from the same cohort who had and had not undergone contralateral prophylactic mastectomy to determine long-term contentment with quality of life and to examine factors associated with less contentment with quality of life.

	METHODS

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Setting
This study was conducted by six healthcare delivery systems participating in the National Cancer Institute-funded Cancer Research Network,¹⁶ which conducts collaborative research to transform cancer prevention and care. Institutional review board approval in accordance with assurances filed with and approved by the Department of Health and Human Services was received at all six systems, with informed consent implied with the return of the survey.

Subjects
Case subjects for this study were survivors from our earlier study of contralateral prophylactic mastectomy efficacy.³ Briefly, eligible women were aged 18 to 80 years and had been diagnosed with unilateral breast cancer during the period from 1979 to 1999 at one of the participating systems. All subjects from the earlier study were included; that study used a case-cohort design in which all women with contralateral prophylactic mastectomy were included plus a small random sample of women without prophylactic mastectomy, frequency-matched within each system on birth year (born before 1945 or born in 1945 or later). Women were identified from automated enrollment, hospitalization, ambulatory care, and cancer registry data. Eligibility was confirmed by medical record review, which included verification that contralateral prophylactic mastectomies were performed for prophylactic reasons. Deceased women were excluded after being identified from chart review, automated enrollment data, and state mortality records. Institutional review boards at four systems required that women be excluded if their physicians declined to approve their recruitment.

Data Collection
Modeled on the method of Dillman,¹⁷ eligible women received an initial mailing, followed by a second mailing to nonrespondents 3 weeks later, followed by a telephone reminder call to nonrespondents 3 weeks after the second mailing. The mailings included a cover letter describing the study, return envelope, survey, and in the first mailing only, an incentive worth 5 US dollars.

Measures
Based on published literature and focus group results, we selected seven domains likely to be impacted by contralateral prophylactic mastectomy: current contentment with quality of life, satisfaction with the procedure, experience of breast cancer thoughts, body image, sexual satisfaction, depression, and health perception. To maximize participation we sought to minimize respondent burden by limiting the estimated time to completion of the survey to 10 to 15 minutes. For each domain, we adapted existing measures by selecting relevant items, and in some cases modifying the wording. For current contentment with quality of life and sexual satisfaction, we used a single item each from the Functional Assessment of Cancer Therapy-Breast Cancer¹⁸ (from the Functional Well-Being and Additional Concerns subscales, respectively). Single items for satisfaction with prophylactic mastectomy and breast cancer concern were developed based on questions used for a breast cancer support program evaluation.¹⁹ Avoiding thoughts about and experiencing intrusive breast cancer thoughts were assessed using questions, five and two respectively, modeled on the Revised Impact of Events scale.²⁰ Body image was assessed using four questions modeled on Hopwood et al.²¹ Depressive symptoms were measured using the complete Center for Epidemiologic Studies-Depression (CES-D) scale²² Health perception was measured using a single item from the Medical Outcomes Study Short Form-36.²³ Demographic questions were drawn from the Behavioral Risk Factor Surveillance System.²⁴ All questions in these domains used Likert scales and asked respondents to rate all items over the last 30 days. Cronbach's alphas for our responses were: avoiding thoughts about and experiencing intrusive breast cancer thoughts, .82; body image, .43; and CES-D, .92.

The study team reviewed the survey to ensure face validity. Pilot testing of the survey was conducted with 11 women from one site using cognitive interviewing techniques^25,26 to identify issues relating to content validity and discomfort with domains. Women in the pilot study were overwhelmingly unwilling to answer a longer and more detailed battery of questions about sexual satisfaction and breast cancer thoughts. The primary explanation given was that their procedure occurred so long ago that these issues were no longer relevant and, in the case of sexual satisfaction, intruded on their privacy.

Statistical Analysis
Two-sided ² tests were used to test for differences between women with and without contralateral prophylactic mastectomy, with P values of less than .05 considered statistically significant. Before modeling, we performed stratified analyses to identify confounding and interaction effects; counfounders were incorporated into the final model and no interaction effects were found. Logistic regression was used to calculate odds ratios and 95% CIs. The final model used included all variables identified as counfounders or in which a confidence interval excluded the null value, except for sexual satisfaction, which was excluded due to a large proportion of omitted responses. Single item measures were dichotomized 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. The correlation was 0.829 for the two items in the first cluster, represented in the analysis by the item self-conscious about appearance, and 0.762 for the two items in the second cluster, represented in the analysis by the item satisfied with appearance when dressed. For avoiding thoughts about and experiencing intrusive breast cancer thoughts, we totaled scored responses as done in the original instrument²⁰ and present the results in tertiles. The CES-D²² was scored as originally designed. All analyses were performed with SAS software (SAS/STAT User's Guide, Version 8.2; SAS Institute, Cary, NC).

	RESULTS

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Survey Response
A total of 1,389 women were included in our earlier study³ of contralateral prophylactic mastectomy efficacy (Fig 1). After excluding the women who were deceased (n = 376), those whose physicians declined their participation (n = 59), and those who had invalid addresses (n = 77), we mailed surveys to 877 women; 637 surveys were returned (72.6%; 73.4% from patients with and 66.7% from patients without contralateral prophylactic mastectomy; P = .144). Respondents and nonrespondents did not differ in demographic characteristics or family history of breast cancer, whether including deceased nonrespondents or limiting the comparison to living original subjects (data not shown). For 48 respondents, 43 with contralateral prophylactic mastectomy and five without, more than 25% of the survey questions were omitted so these respondents were eliminated from the analysis. We excluded from the full analysis but described the results for nine respondents who developed subsequent breast cancer (five women with contralateral prophylactic mastectomy; four without). The final group of 580 respondents included 519 women with and 61 women without contralateral prophylactic mastectomy.

View larger version (32K): [in this window] [in a new window]   Fig 1. Case subject eligibility and response. CPM, contralateral prophylactic mastectomy; PM, prophylactic mastectomy.

Factors Associated With Less Contentment With Quality of Life Among All Respondents
Among all women, less contentment with quality of life was associated with poor or fair general health perception (odds ratio [OR], 7.0; 95% CI, 3.4 to 14.1); possible depression (OR, 5.4; 95% CI, 3.1 to 9.2); dissatisfaction with appearance when dressed (OR, 3.5; 95% CI, 2.0 to 6.0); self-consciousness about appearance (OR, 2.0; 95% CI, 1.1 to 3.7); and avoiding thoughts about breast cancer (modest: OR, 2.2; 95% CI, 1.1 to 4.5; highest: OR, 1.7; 95% CI, 0.9 to 3.2; Table 3). Less contentment with quality of life was also associated with dissatisfaction with sex life (OR, 4.1; 95% CI, 2.1 to 8.1) but because 49 women elected to omit this question we could not adjust for this variable in all models. Less contentment with quality of life was not associated with contralateral prophylactic mastectomy (OR, 0.7; 95% CI, 0.3 to 1.5) nor with undergoing reconstruction, breast cancer concern, experiencing intrusive breast cancer thoughts, age, race/ethnicity, education, year of breast cancer diagnosis, or body mass index. Adjusting for the statistically nonsignificant variables did not alter the results (data not shown).

Contentment With Quality of Life in Women With Subsequent Breast Cancer
The nine women who experienced breast cancer on average 4 years after their initial diagnosis were not included in full analyses due to their unique life experience and the small sample size. However, of the five women who experienced breast cancer after contralateral prophylactic mastectomy, three reported somewhat, a little bit, or no contentment with quality of life, but none reported dissatisfaction with their decision to undergo the procedure. All four women who had not undergone contralateral prophylactic mastectomy and later developed breast cancer reported somewhat, a little bit, or no contentment with quality of life.

	DISCUSSION

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We found a large majority of women (87%) were satisfied with their decision to undergo contralateral prophylactic mastectomy after being diagnosed with breast cancer from 1979 to 1999, two to 23 years before being surveyed. Current breast cancer concern was common, but reported by fewer women with prophylactic mastectomy (50%) than women without the procedure (74%). Three quarters of the women, regardless of having undergone contralateral prophylactic mastectomy or not, were content with their quality of life. Similar proportions of women with and without prophylactic mastectomy reported poor general health perception, depression, body image and sexual satisfaction issues, and avoiding thoughts about breast cancer. The prevalence of possible depression and low general health perception among our respondents is quite comparable to estimates from national studies.^27,28 Among all women, those with less contentment with quality of life were more likely to have poor body image, reporting self-consciousness about their appearance and dissatisfaction with their appearance when dressed, avoiding thoughts about breast cancer, reporting dissatisfaction with their sex life, possibly having depression, and having low general health perception. These results suggest that common experiences such as aging and surviving breast cancer drive psychosocial outcomes more than contralateral prophylactic mastectomies have done several years in the past.

Both of the previous studies of psychosocial outcomes after contralateral prophylactic mastectomy reported high levels of satisfaction with the procedure and generally positive outcomes. In a volunteer national registry, 6% of women regretted their decision to undergo the procedure. Regret was associated with physician initiation of discussions about prophylactic mastectomy, poor cosmetic results, diminished sexuality, and lack of knowledge about alternatives to the procedure.⁸ Among a cohort of more than 500 women receiving contralateral prophylactic mastectomy at a referral clinic, 83% were satisfied with their procedure a mean of 10 years later. Dissatisfaction was associated with reconstruction complications, body image concerns, and life stress, but most women reported neutral or favorable outcomes in other psychosocial domains.⁷ Neither study addressed global quality of life. In addition, both studies used researcher-designed measurement instruments, which were apparently not based on other instruments, and were conducted in a select patient group without a comparison group. Our population-based study addressed quality of life using measures based on validated instruments and included a comparison group.

Several studies of psychosocial outcomes have been done after bilateral prophylactic mastectomy in women without breast cancer but who had elevated breast cancer risk. These studies found that most women were satisfied with their decision and the procedure, and that satisfaction was associated with reduced worry about developing breast cancer and improved body image.^10,13,15 Regret after bilateral prophylactic mastectomy was rare, and associated with poor body image, sexual dysfunction, and a lack of information before the procedure.^9,12 Similarly, poor quality of life was associated with ongoing cancer-related distress, poor body image, and psychological morbidity.^10,11,15 Even though women with contralateral prophylactic mastectomy have experienced breast cancer, making them quite different from those with bilateral prophylactic mastectomy, comparing the results of these studies to ours suggests that the psychosocial outcomes are similar in the two groups.

Studies of breast cancer survivors not undergoing contralateral prophylactic mastectomy have reported good quality of life for 2 to 3 years,²⁹ 5 years,³⁰ 8 years,³¹ and 5 to 10 years³² after diagnosis. None of these studies searched for associations between quality of life and other factors. Although the specific measures used varies, the results consistently showed that a large proportion of women with a history of breast cancer achieved good quality of life, as was found in our study among breast cancer survivors who did and did not undergo contralateral prophylactic mastectomy. In addition, as one would expect, women in our study who underwent prophylactic mastectomy were less likely to report concern about developing breast cancer.

Because our study used a cohort of women assembled from multiple community-based healthcare delivery systems, our results likely apply to a broad range of women diagnosed with breast cancer in the community, unlike studies based in referral centers. However, because the women in our study had little or no recorded family history of breast cancer, and the vast majority had not undergone genetic testing, our results cannot be generalized automatically to women with a family history of breast cancer or BRCA1 or BRCA2 mutations. Additional methodologic strengths of our study include the use of an appropriate comparison group and a careful survey development process.

A limitation of our study is the cross-sectional assessment of quality of life using women from an existing cohort, limiting our ability to examine temporal associations and constraining the sample size. Without preprophylactic mastectomy assessment of psychosocial and other factors, we are unable to determine whether and the degree to which women's variations in contentment and satisfaction changed from before the procedure and over time. A prospective study powered to detect clinically significant differences in psychosocial outcomes over time could help identify women most likely to benefit from prophylactic mastectomy. However, conducting such a study in a population-based sample cared for in community clinics will require a large number of collaborating sites and many years of follow-up.

Another potential limitation of our study relates to the measurement instruments. Because the survey was part of a study that also included women without a history of breast cancer, we were unable to directly use many of the components of instruments validated in women with breast cancer, such as the Functional Assessment of Cancer Therapy-Breast Cancer.¹⁸ In addition, our pilot study raised concerns about the length of the survey and the potentially offensive nature of scales selected for several domains. Including all components of the validated scales we used to develop survey questions would have doubled the length of the survey, which our pilot testing suggested would markedly decrease the overall response rate and increase the amount of missing data. To balance internal and external validity, we created a survey with strong face validity, modeled as closely as possible to instruments used in previous studies. Although we did achieve a respectable response rate, verified that respondents are similar to nonrespondents in basic demographic characteristics, and reported high Cronbach's alphas for the multi-item measures used in the study, our survey was not psychometrically validated and may have been inadequate to detect subtle differences in psychosocial outcomes between women with and without contralateral prophylactic mastectomy.

Contralateral prophylactic mastectomy has been shown to reduce breast cancer morbidity and mortality.^3-5 We found that a large majority of women undergoing this procedure were satisfied with their decision and reported contentment with quality of life comparable with breast cancer survivors who did not undergo the procedure. Furthermore, contralateral prophylactic mastectomy was associated with less breast cancer concern. We concur with a recent editorial in which Schwartz³³ concluded that "concerns about adverse psychosocial outcomes should not be an impediment to raising the option of contralateral prophylactic mastectomy with high-risk patients," although patients should receive counseling on the "medical and psychosocial risks and benefits of contralateral prophylactic mastectomy."

	Authors' Disclosures of Potential Conflicts of Interest

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The authors indicated no potential conflicts of interest.

	Author Contributions

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Conception and design: Ann M. Geiger, Carmen N. West, Larissa Nekhlyudov, Lisa J. Herrinton, Andrea Altschuler, Sharon J. Rolnick, Emily L. Harris, Sarah M. Greene, Joanne G. Elmore, Karen M. Emmons, Suzanne W. Fletcher Provision of study materials or patients: Ann M. Geiger, Carmen N. West, Larissa Nekhlyudov, Lisa J. Herrinton, Andrea Altschuler, Sharon J. Rolnick, Emily L. Harris, Sarah M. Greene, Suzanne W. Fletcher Collection and assembly of data: Ann M. Geiger, Carmen N. West, Larissa Nekhlyudov, Lisa J. Herrinton, In-Liu A. Liu, Andrea Altschuler, Sharon J. Rolnick, Emily L. Harris, Sarah M. Greene, Joanne G. Elmore, Karen M. Emmons, Suzanne W. Fletcher Data analysis and interpretation: Ann M. Geiger, Carmen N. West, Larissa Nekhlyudov, Lisa J. Herrinton, In-Liu A. Liu, Andrea Altschuler, Sharon J. Rolnick, Emily L. Harris, Sarah M. Greene, Joanne G. Elmore, Karen M. Emmons, Suzanne W. Fletcher Manuscript writing: Ann M. Geiger, Carmen N. West, Larissa Nekhlyudov, Lisa J. Herrinton, In-Liu A. Liu, Andrea Altschuler, Sharon J. Rolnick, Emily L. Harris, Sarah M. Greene, Joanne G. Elmore, Karen M. Emmons, Suzanne W. Fletcher Final approval of manuscript: Ann M. Geiger, Carmen N. West, Larissa Nekhlyudov, Lisa J. Herrinton, In-Liu A. Liu, Andrea Altschuler, Sharon J. Rolnick, Emily L. Harris, Sarah M. Greene, Joanne G. Elmore, Karen M. Emmons, Suzanne W. Fletcher

 

	NOTES

 
Supported by the National Cancer Institute (Grants No. U19 CA79689 and R01 CA090323).

Presented in part at the Annual Meeting of the American Psychosocial Oncology Society, Phoenix AZ, January 29, 2005; the International Society for Quality of Life Research Symposium, Boston, MA, June 27, 2004; the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004; and the 6th World Congress of Psycho-Oncology, Banff, Canada, April 25, 2003.

This article presents the original work of the authors and is not under review elsewhere.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

	REFERENCES

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Submitted March 13, 2005; accepted January 5, 2006.

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