Originally published as JCO Early Release 10.1200/JCO.2004.05.192 on December 14 2004

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Decision-Making About Tamoxifen in Women at High Risk for Breast Cancer: Clinical and Psychological Factors

From the Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.

Address reprint requests to Sharon L. Bober, PhD, Dana-Farber Cancer Institute, David B. Perini Quality of Life Clinic, D321, 44 Binney St, Boston, MA 02115; e-mail: sharon_bober{at}dfci.harvard.edu

	ABSTRACT

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PURPOSE: To explore the health-related and psychological factors that influence decision making about tamoxifen (Nolvadex; AstraZeneca, Waltham, MA) chemoprevention in women at increased risk for developing breast cancer.

METHODS: This study involves the assessment of 129 women eligible to take tamoxifen following cancer-risk counseling. Treatment decision and decision satisfaction were measured at 2 and 4 months following counseling. Health-related factors included physician recommendation, personal and family-related health history, and concern about side effects. Psychological factors included breast cancer–related anxiety, risk perception, and depression.

RESULTS: At 2 months’ follow-up, 44% of participants declined tamoxifen treatment. This number increased to 49% at 4 months. Personal and family health history were not related to the decision, but history of abnormal biopsy did predict tamoxifen use. Physician recommendation was highly correlated with treatment decision. Concern about side effects was related to the decision to decline treatment. Breast cancer–related anxiety and heightened risk perception were associated with the decision to take tamoxifen. However, anxiety and psychological distress were also negatively related to treatment satisfaction.

CONCLUSION: Decision-making about tamoxifen is complex, and many eligible women decline treatment or remain undecided. Findings call for further educational follow-up with high-risk women after they undergo initial counseling. Factors related to misperceptions of risk and side effects, as well as psychological distress, may be particularly important targets for intervention.

	INTRODUCTION

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For the first time, women at increased risk for breast cancer have the option to take a chemoprevention agent, tamoxifen, which may significantly reduce their risk of developing breast cancer. In contrast to health-promoting strategies that target early detection, such as mammography and breast self-exam, tamoxifen, a selective estrogen receptor moderator (SERM), previously used to treat breast cancer, has become the first US Food and Drug Administration–approved drug for use in preventing breast cancer in high-risk women. Tamoxifen has been shown to reduce women’s risk of invasive and noninvasive breast cancer by almost 50%.¹ However, tamoxifen use is linked to many increased health risks, such as increased risk of endometrial cancer, thromboembolic events, cataracts, and exaggeration of menopausal symptoms such as hot flashes and night sweats.² Thus, women at increased risk for breast cancer now have available an effective chemoprevention drug that also demands a complex trade-off between potential risks and benefits. Potential worries and misconceptions about breast cancer risk and statistical probabilities³ may amplify the difficulty in deciding on tamoxifen use.

Although chemoprevention for cancer is still a relatively new domain, there is tremendous effort underway to expand the development of new chemoprevention agents for breast and other cancers.⁴ Yet, there are scant data focusing on decision-making about chemoprevention, including tamoxifen. There is the suggestion that high-risk women are likely to opt against tamoxifen for reasons such as fear of side effects, bias against taking medication, and difficulty in understanding information about tamoxifen.^5,6 However, this research has largely focused on knowledge and attitudes about tamoxifen,^7,8 and psychological factors have received little attention. Previous research with high-risk women has demonstrated that these women are both vulnerable to psychological distress^9,10 and potentially motivated by heightened anxiety to engage in health-protective behavior.¹¹ This study is the first to examine decision-making about tamoxifen among high-risk women, with regard to both psychological variables such as breast cancer–related anxiety, general distress and perceived risk, as well as known factors in clinical decision-making such as physician recommendation, fear of side effects, and family health history.¹² We predicted that women who experienced greater breast cancer–related anxiety and had greater perceived risk of breast cancer would be more likely to opt for tamoxifen compared with women with less breast cancer–related anxiety and lower perceptions of risk.

In addition, we were interested in examining decision satisfaction. Decision satisfaction has been shown to be highly correlated with measures of decision certainty.¹³ That is, individuals who are satisfied with their decision are more likely to carry out the decision that has been made. Because the recommended regimen for tamoxifen consists of daily medication for 5 years, we wanted to learn not only about how initial decisions are made, but also to examine a factor that may be linked to adherence over time.

	METHODS

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Study Population
The protocol was approved by the Beth Israel Deaconess Medical Center (BIDMC) institutional review board. All participants were eligible for tamoxifen and were counseled by one of two oncologists associated with the study (N.M.T. and R.B.D.) in one of three settings: (1) the Cancer Risk and Prevention Program at BIDMC; (2) an introductory meeting for the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR or P-2 trial); or (3) physician clinical practice.

Treatment guidelines for use of tamoxifen with high-risk women are based on the Gail model,¹³ a well-validated algorithm calculating absolute breast cancer risk by taking into account various risk factors including age, number of first-degree relatives with breast cancer, and number of previous breast biopsies. Specifically, women aged 35 years with a 5-year risk of developing breast cancer 1.7% are eligible for tamoxifen.¹⁴ Postmenopausal women meeting the same criteria are also eligible to participate in the STAR trial, a randomized study comparing 5 years of tamoxifen and raloxifene, another SERM.

Counseling about tamoxifen included an evaluation for breast cancer risk and a discussion of benefits and personal risk of potential complications from treatment. Although patient-physician communication was not based on a scripted protocol, the two physician-investigators attempted to insure consistency in information given about chemoprevention. Shortly after counseling, women completed questionnaires assessing demographics, personal and family health history, and psychological variables (time 1). The variables chosen for inclusion were based on previous research studying medical decision-making in the area of cancer risk.^10,14,15 Approximately 2 months later, all women were contacted by telephone and were asked about treatment decision (time 2) and decision satisfaction. At 4 months, all women were again contacted by telephone to evaluate the same variables (time 3).

Measures
Sociodemographics. Age, race, marital status, education and employment were assessed.

Health-related variables. (1) Personal and family health history of all cancers and other existing health conditions affecting eligibility to take tamoxifen (eg, blood clots, stroke) were assessed by self-report using a checklist format. (2) Physician recommendation assessment explored women’s reports of all physician (eg, gynecologist, primary care physician, oncologist) recommendations about tamoxifen. (3) Breast cancer risk perception was measured using a previously validated Likert-style item eliciting comparative perceptions of breast cancer risk: "As compared to other women your age, what is your risk of getting breast cancer?" (1 = much lower to 7 = much higher).^3,16

Self-reported psychological variables. (1) Distress was assessed using two measures, the Center for Epidemiological Studies Depression Scale (CES-D)¹⁷ and the Intrusion Subscale of the Revised Impact of Event Scale (R-IES).¹⁸ The CES-D is a widely used measure for detecting depressive symptomatology. The R-IES has been used to measure breast cancer–specific distress and the Intrusion Subscale has been used to specifically assess severity and frequency of intrusive thoughts and feelings related to an increased risk of breast cancer.^10,19 (2) Breast cancer worry was measured with a previously developed scale composed three Likert-style items assessing worry about breast cancer.²⁰ (3) Optimism was measured by the Life Orientation Test,²¹ an eight-item self-report measure assessing general attitudes of optimism about future outcomes. (4) Motivational orientation was measured by the Treatment Self-Regulation Questionnaire (TRSQ), a 15-item measure assessing individual motivational styles for participating in treatment.²² The scales measuring autonomy and impersonal style were used in this study. Decision satisfaction was assessed based on a six-item scale previously developed to measure medical decision satisfaction.¹¹

Statistical Analyses
Data were summarized as mean ± standard deviation (SD) or number (percentage) of subjects. The relationships of health-related variables and physician recommendations with decision outcome (as a dichotomous variable of whether one decided to opt for chemoprevention or not) were examined using Fisher’s exact tests and using logistic regression. The continuous psychosocial variables were compared among the treatment decision groups using analysis of variance. Student-Newman-Keuls (SNK) was used for post hoc pair-wise comparisons. t tests were used to compare women who were undecided about their treatment decision with women who had made a decision (either for or against treatment). Statistical analyses were conducted with SAS version 7.0,²³ and two-tailed probabilities were reported.

	RESULTS

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Sociodemographic Characteristics
Of the 158 high-risk women who agreed to participate, 129 (82%) completed questionnaires at baseline (time 1) and made up the study sample. Subjects ranged in age from 35 to 73 (mean ± SD, 52 ± 7.8 years; Table 1), and almost all subjects (96%) reported their race/ethnicity as white. One hundred five women (82%) completed at least 16 years of education, 93 women (72%) were currently employed, and most were married (74%).

Psychological Variables: Health Beliefs, Anxiety, Perceived Risk
Concern about side effects of tamoxifen, measured on a 1 to 5 scale, was a significant factor (F = 4.28, R² = 0.09; P < .006) in treatment decision (Table 4). Post hoc comparisons indicate that women who enrolled onto the STAR trial were significantly less concerned about side effects than women in the other decision groups, including those who decided to take tamoxifen. In addition, women who declined treatment felt more strongly that medication would not be able to prevent cancer (F = 6.22, R² = 0.12; P < .001) than women in all other decision groups (Table 4).

Decision Satisfaction
Decision satisfaction was also assessed, and there were no differences between women opting for or against chemoprevention. Women who were undecided about treatment were compared with women who had made a decision (either for or against treatment). Undecided women were less satisfied that they were adequately informed about their decision (t = –8.69, P < .0001) compared with women who made a treatment decision. In addition, when asked to cite their sources of information about tamoxifen (eg, medical professionals, the Internet, cancer hotline), undecided women cited fewer sources of information about tamoxifen (t = –2.19, P < .02) than women who had made a treatment decision.

Multiple regression procedures were used to look at the relationship between the outcome variable of decision satisfaction and psychological variables. Among women who made a treatment decision, it was found that women who reported more depressive symptoms were less satisfied (F = 7.48, R² = 0.06; P < .007), as were women who reported more worry about breast cancer (F = 9.97, R² = 0.08; P < .002). Life orientation (ie, optimism) did not predict decision satisfaction. However, women with a more autonomous motivational style (ie, perceived volition and competence) felt more satisfied with their treatment decision (F = 3.80, R² = 0.04; P < .05). In contrast, women reporting greater impersonal motivational style (perceived helplessness and lack of competence) were significantly less satisfied with their treatment decision (F = 4.33; R² = 0.04, P < .04).

	DISCUSSION

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Interestingly, greater family history of breast cancer was not related to treatment decision, whereas personal history of having an abnormal breast biopsy was highly correlated with the decision to take tamoxifen. Although family history has frequently been identified as a key motivator of health behavior,²⁴ previous studies have focused on decisions about screening,¹⁵ rather than chemoprevention. One explanation is that when women receive an abnormal biopsy result, they feel personally more vulnerable, and are thus motivated to engage in a more active type of health behavior despite the potential for negative side effects.

Physician recommendation has been strongly linked to mammography adherence²⁵ as well as the likelihood that a woman would join the earlier breast cancer chemoprevention trial.²⁶ Women in this study were more likely to opt for tamoxifen if they reported receiving a physician recommendation. Of note, although all women in this study were counseled by a physician on their eligibility (including risks and benefits) to take tamoxifen, not all women reported receiving a physician recommendation. Because the current study was limited by not having directly measured patient-physician communication, we do not know how accurately patient report paralleled the actual interaction. In an effort to clarify this finding, women’s age and health history were examined in relation to report of physician recommendation. Although age was not related, history of abnormal biopsy was strongly correlated with women’s reports of physician recommendation. It is plausible that history of abnormal biopsy served as a salient risk marker for physicians who, in turn, became more emphatic in the way they discussed tamoxifen as a treatment option, thus resulting in some women being more likely to perceive a recommendation. Physician-patient communication is undoubtedly a determining element affecting patients’ attitudes and decisions about chemoprevention. Further study focusing on patient-physician communication as well as patient perceptions of physician recommendation is warranted.

Consistent with previous research,^5,6 women were generally concerned about side effects of tamoxifen, and increased concern about side effects was associated with the decision to decline treatment. Of note, women who opted for the STAR trial were significantly less concerned about side effects than women in all other decision groups. STAR trial participants receive close monitoring, and it is possible that the awareness of getting close medical attention mitigates concerns about side effects. However, it is also possible that women who are less anxious to begin with are more likely to enroll in a randomized trial. These findings underscore the need for women to be fully informed about the actual likelihood of side effects, and plans for managing potential complications should be thoroughly discussed.

Women who opted against treatment had a significantly stronger endorsement of the belief that medication is not able to prevent breast cancer. These results are consistent with previous research showing that health beliefs regarding cancer prevention have a critical impact on whether at-risk individuals engage in screening and other preventive measures.²⁷ Future study should evaluate the specific links between health beliefs and use of chemoprevention.

Numerous studies have addressed the relationship between psychological distress (eg, worry and emotional concern) and adherence to preventive health behaviors among high-risk women.^9,28 Women with increased breast cancer worry are more likely to have a mammogram and a clinical breast exam.²⁰ As predicted, women who opted to take tamoxifen had elevated levels of anxiety and breast cancer–related worry compared with women in other decision groups. These findings suggest that anxiety may be a mobilizing force for women to engage in health-protective behavior, including chemoprevention.

Another important issue is the perception of health risk. Perception of risk is rarely a direct representation of correctly understood probability information,^29,30 but rather a conception that reflects beliefs and affects in addition to specific knowledge. Although all of the women in this study were at higher risk for breast cancer than the general population, women who chose tamoxifen perceived themselves at greater risk than those who decided against chemoprevention. It may be that within a high-risk population seeking consultation, perception of risk is a motivating factor for women to engage in preventive measures. In general, these results underscore the need for physicians to elicit women’s perceptions and health beliefs in order to tailor counseling and facilitate decision-making based on clear and accurate risk perceptions.

One of the more surprising findings from the present study was the number of women who remained undecided about treatment on follow-up. Undecided women reported that they were less adequately informed about tamoxifen and that they received information from fewer sources. One limitation of the current study is that it is not known whether or not these women actually received less adequate information during counseling. Since physician-patient interactions were not taped, it is not possible to assess the extent of discussion that occurred with each woman. Nevertheless, this finding suggests that women may have varying needs for information and that further consultation may be necessary after initial counseling in order to assess whether women feel adequately informed and to address requests for additional information.

Interestingly, levels of decision satisfaction did not differ between women deciding for or against chemoprevention. However, women who endorsed both greater depressive symptoms and anxiety-related symptoms were less satisfied with their decision. Previous findings have shown that individuals who are satisfied with their decisions are more likely to carry out their decision, whereas decision uncertainty often seems to lead to a state of inaction.³¹ Thus, our findings suggest that among women opting for chemoprevention, those experiencing psychological distressed may be vulnerable to prematurely discontinuing treatment.

In addition, women who felt more autonomous (having a greater sense of choice and competence) about their treatment decision were significantly more satisfied with their decision, whereas women who felt greater helplessness and less competent about this decision felt less satisfied. This result underscores the importance of shared decision making that, in particular, supports a woman’s sense of self-efficacy. When physicians actively engage patients in the decision-making process, patients report making more satisfying decisions, and outcomes have been shown to be more long-lasting.³²

The results of the present study underscore many of the complications surrounding decision making about breast cancer chemoprevention. In contrast to previous research suggesting that high-risk women would overwhelmingly reject the option of chemoprevention,^5,7 findings from the present study were more variable. Although both health-related and psychological factors may be important predictors of chemoprevention uptake, factors such as heightened anxiety may also be linked to lower decision satisfaction and potentially lead to lower adherence. High-risk women would likely benefit from receiving counseling about chemoprevention that addresses both health-related and psychological concerns. Future research is needed to develop tailored interventions that will optimize informed decision making and promote treatment adherence.

	Authors’ Disclosures of Potential Conflicts of Interest

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The authors indicated no potential conflicts of interest.

	Acknowledgment

 
We thank Dr Michael Diefenbach for his contribution to the development of this study and Drs Lisa Diller and Mary Anne Badaracco for their consultation.

	NOTES

 
Supported by a grant from the Massachusetts Breast Cancer Research Grant Program (S.L.B.).

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

	REFERENCES

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Submitted May 29, 2003; accepted September 23, 2004.

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This Article Abstract Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Bober, S. L. Articles by Tung, N. M. Search for Related Content PubMed PubMed Citation Articles by Bober, S. L. Articles by Tung, N. M.