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Women's Decision-Making Roles Regarding Contralateral Prophylactic Mastectomy
Affiliations of authors: Department of Ambulatory Care and Prevention, Harvard Pilgrim Health Care, Boston, MA (LN, MB, SWF); Division of Research, Northern California Kaiser Permanente, Oakland, CA (LJH, AA); Center for Health Studies, Group Health Cooperative, Seattle, WA (SMG); Health Partners, South Minneapolis, MN (SR); Division of General Internal Medicine, University of Washington, Seattle (JGE); Center for Health Research, Kaiser Permanente Northwest, Portland, OR (ELH); Research and Evaluation Department, Kaiser Permanente Southern California, Pasadena, CA (AL, AMG); Center for Community Based Research, Dana-Farber Cancer Institute, Boston, MA (KME)
Correspondence to: Larissa Nekhlyudov, MD, MPH, Department of Ambulatory Care and Prevention, 133 Brookline Ave., 6th floor, Boston, MA 02215 (e-mail: larissa_nekhlyudov{at}harvardpilgrim.org).
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ABSTRACT |
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Background: Contralateral prophylactic mastectomy (CPM) is the removal of a nonaffected breast in a woman with unilateral breast cancer and is effective in reducing the risk of recurrences. Little is known about women's decision-making roles regarding CPM. Methods: Women aged 18–80 years with CPM performed at one of six health maintenance organizations between 1979 and 1999 were surveyed. We determined women's reported decision-making roles at the time of CPM, analyzed their trends over time, and explored the association between decision-making roles and psychosocial outcomes following CPM. Results: We received 562 responses (response rate = 73%); 431 completed items needed for this analysis. Most respondents were white, younger than 55 years at CPM, married, and had CPM within 10 years of completing the survey. Forty-five percent made the decision to undergo CPM alone, 37% considered their doctor's opinion, 15% shared the decision with their doctor and only 3% reported their doctor primarily made the decision. Women reporting active roles were more likely to be younger (P<.0008), college educated (P<.0001) and have CPM more recently (P = .002). Compared with those sharing the decision with their doctors, women with active roles were twice as likely to be satisfied 6 months following CPM (odds ratio [OR] = 2.2, 95% confidence interval [CI] = 1.1 to 4.2) and report current concern about breast cancer (OR = 1.9, 95% CI = 1.0 to 3.4). Conclusions: Most women reported active or shared roles in decision making regarding CPM, particularly younger women, those with college education, and those with recent CPM. Women with active roles were more often satisfied in the short term but were also more likely to report current concern about breast cancer. Whether higher concern is related to insufficient input from clinicians should be explored. Prospective data are needed.
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INTRODUCTION |
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The patient–physician relationship is shifting from the traditional paternalistic model in which decisions are made primarily by the doctors to one in which patients are informed about their health care and treatment options and are encouraged to participate in the decision-making process. This latter approach has been termed "informed decision making," a process in which a patient is informed about the risks, benefits, and alternatives; weighs her own values; and engages in the decision-making process at the level that she desires, or "shared decision making," a process that also incorporates the provider's preference (1–4). Patient involvement in decision making is particularly important when the effect of the decision or the nature of the outcome may be substantial (4–6). Prior studies suggest that patients who engage in the decision-making process have greater knowledge, more realistic expectations, less uncertainty about a course of action to take, and often greater satisfaction (7).
There has been extensive interest in shared decision making regarding treatment among women with breast cancer (8–11). However, we found only one study that has addressed decision making by women with breast cancer who had a contralateral prophylactic mastectomy (CPM) (12). CPM is a surgical removal of the nonaffected breast in a woman with unilateral breast cancer and reduces the risk of contralateral breast cancer by more than 90% (13–15). Because of the efficacy of CPM among women at high risk for breast cancer recurrence, this may be an option for 10 000–20 000 women in the United States annually (16).
Even though CPM is efficacious, the decision to undergo the procedure is substantial and requires women to weigh the risks and benefits, as well as their individual values. Although there is mixed evidence on the roles patients wish to play in the decision-making process (17), data suggest that as patients move from wellness to illness, their preferences for decision-making roles change from active to passive (8). What roles women take in the decision-making process regarding CPM and whether decision-making roles are related to women's psychosocial outcomes following CPM are unclear. Data in this area would help providers guide women in the decision-making process regarding CPM.
The goals of our study were to determine women's decision-making roles regarding CPM, including trends over time, and to explore the association of decision making roles with psychosocial outcomes, including satisfaction, long-term concern about breast cancer, and depressive symptoms.
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METHODS |
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Design and Setting
Women were identified from an existing cohort examining the efficacy of CPM in reducing the incidence of contralateral breast cancer and breast cancer death (15). The study was conducted under the auspices of the National Cancer Institute–funded Cancer Research Network (CRN), which consists of the research programs, enrollee populations, and databases of 11 integrated healthcare organizations that are members of the HMO Research Network. The health care delivery systems participating in the CRN are as follows: Group Health Cooperative, Harvard Pilgrim Health Care, Henry Ford Health System/Health Alliance Plan, HealthPartners Research Foundation, the Meyers Primary Care Institute of the Fallon Healthcare System/University of Massachusetts, and Kaiser Permanente in six regions (Colorado, Georgia, Hawaii, Northwest [Oregon and Washington], Northern California, and Southern California). The 11 health plans have nearly 10 million enrollees. The CRN conducts collaborative research on variations in cancer prevention and treatment policies and practices. Six sites participated, including: Group Health Cooperative, Washington; Harvard Pilgrim Health Care, Massachusetts; Health Partners, Minnesota; and three Kaiser Permanente regions: Northwest (Oregon) and Northern and Southern California. The institutional review boards from all six sites approved the study, with consent implied by return of the surveys.
Subjects
Details about the study cohort are available elsewhere (15). In brief, all women (n = 1065) aged 18–80 years who had CPM between 1979 and 1999, who were members of one of the participating HMOs, and who had a personal history of breast cancer were initially eligible. This study sample was identified using automated enrollment, hospitalization, ambulatory care, and cancer registry data; eligibility was confirmed by medical record review. We excluded from the sample deceased case patients identified through chart review, automated health plan data, and state mortality records (n = 178). Women whose physicians declined to give approval for their recruitment were also removed (n = 52). Another 69 women were not contacted due to incorrect addresses. Of the original cohort, 766 women were invited to participate in the survey.
Data Collection
Subjects were mailed a self-administered survey that took approximately 15 minutes to complete. A $5 incentive was offered with the initial mailing. Nonresponders received a reminder mailing and telephone call 3 weeks following the initial contact. Survey data were double-entered and verified by a single company.
Survey Measures
The survey development included expert review for validity and readability, focus groups, and pilot testing. The instrument included the following domains: women's roles in the CPM decision, past and current satisfaction with CPM, current concern about getting breast cancer again, and depressive symptoms, as well as patient characteristics including age, race/ethnicity, education, marital status, breast cancer stage at CPM, and current perception of general health.
We assessed women's decision-making roles at the time of CPM using a modified Control Preference Scale (8). This scale was developed based on a grounded theory of how decisions are made among patients with life-threatening diseases and consists of a card-sorting technique (8). It has been previously validated to assess both preferences for and experiences in the decision-making process (8,9) and has been modified for use in mailed and/or telephone-administered surveys (9,18,19). Although there are various ways of conceptualizing the extent of patient involvement in decision making (3,4,20), it is most consistently categorized into active or "informed choice," whereby the patient seeks information and plays an active role in decision making; "shared decision making," whereby the patient and the provider exchange information and preferences and make the decision together; and the "paternalistic" approach, whereby the patient takes a passive role and the decision is made by the provider. To assess the roles women assumed in the decision to undergo CPM, we asked which of the five statements reflected their decision: "I made the final decision to have surgery/I made the final decision to have surgery after seriously considering my doctor's opinion/My doctor and I shared responsibility for the final decision to have surgery/My doctor made the final decision about my surgery, but seriously considered my opinion/My doctor made the final decision about my surgery."
Satisfaction with the decision to have CPM at 6 months following the surgery and current (at the time of the survey) were measured using modified tools from a prior survey (21). Items included a four-point scale ranging from very satisfied to very unsatisfied. Concern about breast cancer (at the time of CPM and current) was measured on a four-point scale ranging from very concerned, concerned, not very concerned, to not concerned at all. Current depressive symptoms were measured by the Center for Epidemiologic Studies Depression Scale (CES-D), a 20-item questionnaire that assesses the frequency and duration of symptoms associated with depression such as trouble sleeping, loneliness, sadness and poor appetite (22). Patient perception of health (scaled from excellent to poor) was measured using one item from the Short Form Health Survey Instrument (MOS SF-36), developed and validated by the Medical Outcomes Study to measure health-related quality of life (23).
Statistical Analyses
Decision-making roles regarding CPM were initially divided into four categories: 1) the woman made the decision alone, 2) the woman made the decision after considering the doctor's opinion, 3) the woman shared the decision with the doctor, and 4) the doctor decided alone/after woman's opinion (the latter category, "passive," combined two roles due to small numbers). Satisfaction items were dichotomized into very/satisfied and very/dissatisfied. Current concern about breast cancer recurrences was dichotomized as very/concerned and not very concerned/not concerned at all. CES-D scores of at least 16 were defined as having currently high depressive symptoms (24). Patient characteristics were categorized as shown in Table 1.
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We used frequency distributions to describe patient characteristics and their decision-making roles, one-way analysis of variance to describe the trends in decision-making roles over time, and chi-square or Fisher's exact tests to examine univariable associations between decision-making roles and patient characteristics and psychosocial outcomes.
In exploratory logistic regression models, we first used four decision-making role categories. After finding similar results among women in the first two categories in both the frequency distributions and modeling, we further collapsed the first two categories (described as "active"); this approach is consistent with the previously described theoretical framework and prior literature (8,18–20). In multivariable logistic regression analyses, we adjusted for covariates found to be statistically significant at the P<.05 level in univariable analyses and those we considered a priori clinically significant (such as race and breast cancer concern at the time of CPM). In the regression analyses, we used the shared role (the woman shared the decision with her doctor) as a referent group. All analyses were performed with SAS software (version 8.2, Cary, NC).
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RESULTS |
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Patient Characteristics and Decision-Making Roles
We received 562 surveys (response rate = 73%); 431 respondents are included in this analysis. We excluded 126 who returned surveys with missing items needed for this analysis and five who developed recurrent breast cancer. Most (86%) respondents were white, younger than 55 years at the time of CPM (71%), had less than college education (57%), and were married (73%, both at the time of CPM and survey). At the time of CPM, 39% had family history of breast cancer, 28% had past benign breast disease, and 81% had localized or in situ breast cancer. Approximately 60% had CPM within the past 10 years and 55% had breast reconstruction. Most (82%) considered themselves to be in excellent to good health at the time of the survey. Compared to the respondents, nonresponders were similar by age, race, breast cancer stage at CPM, and years since the procedure (data not shown).
About half (45%) of women reported that they made the final decision about CPM alone, 37% reported making the decision after considering their doctor's opinion, and 15% shared the decision-making responsibility with their doctor. Only 3% reported that their doctor made the decision alone or after considering the woman's opinion (Table 1). There were statistically significant differences among the four groups in age at the time of CPM, college education, and years since CPM. Women who made the decision alone were slightly more likely to have a college education (51%) than those who made the decision after their doctor's opinion (45%) and much more likely than those who shared the decision with their physicians (19%; P<.0001). Most (71%) of the women who reported a passive role were between the ages of 55 and 64 at the time of CPM, statistically significantly older than women reporting other decision-making roles (P = .0008). Time since CPM was related to the decision-making roles (Fig. 1); women who played more active roles in the decision, on average, had had CPM more recently than those who reported passive roles.
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Decision-Making Roles and Psychosocial Outcomes
There was a statistically significant association between women's reported decision making roles and their satisfaction with the decision to undergo CPM 6 months after the procedure and their current depressive symptoms (Table 2). Eighty-three percent of women making their decision alone, 88% of those deciding after their doctor's opinion, 72% of those sharing the decision with their doctor, and 69% of those reporting their doctor making the decision alone/after considering their opinions (69%) were satisfied with their decision 6 months after the CPM (P = .02). Depressive symptoms were more likely among women who reported sharing the decision with their providers (38%) than those reporting other decision-making roles (21%–29%; P = .04).
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Though the results did not reach statistical significance, concern about breast cancer recurrence appeared higher among women deciding alone (53%) and after their doctor's opinion (51%) than those sharing the decision with their doctor (34%) and those who reported their doctor making the decision alone/after considering their opinions (41%; P = .06).
In exploratory multivariable analyses, we found that women who reported active roles were about twice more likely to be satisfied with their decision six months after CPM (odds ratio [OR] = 2.2, 95% confidence interval [CI] = 1.1 to 4.2) than those who shared the decisions with their doctors (Table 3). Women who had more active roles were also twice as likely to be currently concerned about breast cancer (OR = 1.9, 95% CI = 1.0 to 3.4). Current satisfaction and depressive symptoms were not independently related to the decision-making roles. We found no statistically significant results among the women reporting passive roles, but were limited by the small number of women in this group.
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DISCUSSION |
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TopNotesAbstractIntroductionMETHODSRESULTSDISCUSSIONReferences |
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We found that most women who underwent CPM reported having an active or shared role in the decision-making process regarding the procedure, particularly younger women, those with college education, and those who had undergone CPM more recently. In exploratory analyses, compared with women who shared the decision with their doctors, those who reported active roles were twice as likely to be satisfied with their decision 6 months after CPM but were more likely to report current concern about breast cancer recurrence. Decision-making roles were not associated with long-term satisfaction with the decision or current depressive symptoms.
Our study is the first, to our knowledge, to focus on women's decision-making roles about CPM, including secular trends and possible associations of decision-making roles with psychosocial outcomes and patient characteristics. The only previous study where decision making among women with CPM was explored was a survey of 296 female volunteer participants in the National Prophylactic Mastectomy Registry (drawn from the readership of a magazine Modern Maturity) (12). In that study, Montgomery et al. found that regret among women who initiated discussion about CPM with their providers was slightly less (5% versus 8%) than in women who reported that their physicians initiated the discussion. The difference was not statistically significant, although the tendency noted by the investigators is consistent with our findings that short-term satisfaction with CPM was higher among women adopting active decision-making roles.
Research on decision making and bilateral prophylactic mastectomy (BPM, a surgical removal of both breasts among women with no breast cancer) has also been limited, although there are more extensive data on psychosocial outcomes following the procedure. Borgen et al. (25) surveyed 370 women with BPM who were drawn from the same cohort as those in Montgomery et al. (12) and found that 21 women reported regrets after having BPM. As suggested by the CPM results, regrets were more common among women who reported the discussion about BPM to be initiated by the physicians rather than by the patients (7% versus 2%; P<.05). Nineteen of these women were then interviewed about their decision-making process and psychological and physical concerns before and after BPM (26).Three additional studies described the psychosocial outcomes following BPM but did not evaluate women's decision-making roles regarding the procedure (27–29).
Our finding that more educated women are more likely to be active in decision making is consistent with findings of prior studies in other clinical areas (8,9,17,30). Women with higher levels of education may have more access to information resources and feel more able (on a par with their doctor) to take responsibility for their decision. Less-educated women may have lower health literacy, which may lead to a less active involvement in the decision making. Focusing on women with lower education and health literacy skills is needed if informed and/or shared decision making is to be encouraged. Our finding that women undergoing CPM more recently had more active decision-making roles is consistent with the growing emphasis on patients' involvement in the decision-making process.
Active decision-making roles have been associated with greater patient satisfaction with treatment and/or screening decisions (7). Our satisfaction results are somewhat inconsistent in that active women were more likely to recall being satisfied with their decision 6 months after CPM than those who shared the decision with their doctors, but long-term satisfaction was similarly high in all groups. Because short-term satisfaction was ascertained retrospectively, our findings about this outcome should be interpreted cautiously. Prospective data would be useful.
The explanation for more frequent concern about breast cancer recurrence among women reporting more active decision-making roles is not clear, though plausible. Overestimation of breast cancer risk might cause disproportionate concern and anxiety leading women to make the CPM decision more independently of their doctors. Taking on active roles may cause women to take on additional responsibility of the decision after CPM, leading them to feel greater concern about recurrences. Alternatively, more active decision makers were more educated and perhaps had more access to medical literature and, more recently, the Internet. As such, they may have been exposed to frightening and/or incorrect information that may have led to greater concern about recurrences. This hypothesis is supported by a study assessing women's preferences for screening mammography; in this study, women who preferred to make the decision alone were more likely to expect bad news from mammograms and feel nervous about screening (18). It is important that providers spend time with all women before and after CPM to assess their knowledge and correct any misperceptions.
Our study population was large and responded to the survey in high numbers. Although responders were mostly white, they are representative of the women who undergo CPM (12). Our sample was also drawn from HMOs in five states, mostly from community-based clinical settings rather than referral centers with select populations. Therefore, our results are likely widely generalizable.
Our study has limitations. First, women were asked to respond to questions regarding their roles in decision making prior to undergoing CPM years before, and therefore some recall bias may have occurred. Because our study was retrospective, it was neither possible for us to ascertain the psychosocial factors that may have existed at the time of CPM nor to assess for causal relationships. Second, our patients were members of HMOs that paid for the CPM; therefore, further data among non–HMO insured patients are needed. Finally, the small number of women who reported passive decision-making roles limited our ability to draw conclusions about this subgroup. Our findings including the passive group did suggest a U-shaped curve in women's responses, rather than a unidirectional relationship as had previously been observed (8,10); however, the linearity of women's level of preferred control over decision making has been previously questioned (18). Decision making is complex; preferences and roles vary by disease state and likely decision type (32,33). Because of the paucity of data on passive decision-making roles for CPM, our study sets the stage for further prospective research.
In conclusion, most women reported being involved in the decision to undergo CPM. Those who were most active in decision making were more likely to be younger, college educated, have had a recent CPM, and be satisfied in the short term. Women reporting active roles were also more likely to be currently concerned about breast cancer risk. Decision-making roles did not have long-term satisfaction implications. Whether more concern about breast cancer among women making the decision alone is related to insufficient input from clinicians should be explored. Our study adds to the scarce literature in this area, but further prospective data are needed.
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NOTES |
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Supported by the National Cancer Institute (U19CA79689 and R01-CA090323).
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