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Women's Interest in Chemoprevention for Breast Cancer
Lori A. Bastian, MD, MPH;
Isaac M. Lipkus, PhD;
Maggie N. Kuchibhatla, PhD;
Haoling Holly Weng, MHS;
Susan Halabi, PhD;
Paula D. Ryan, MD, PhD;
Celette Sugg Skinner, PhD;
Barbara K. Rimer, DrPH
Arch Intern Med. 2001;161:1639-1644.
ABSTRACT
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Background Chemoprevention is the use of pharmacologic or natural agents to inhibit
the development of cancer. Tamoxifen citrate is the only approved chemopreventive
agent for breast cancer. We sought to determine whether women are interested
in taking a drug to prevent breast cancer and to assess the relationship between
objective and subjective breast cancer risk and interest in chemoprevention.
Methods We conducted telephone interviews (November 3, 1997, to May 6, 1998)
among a community sample of women aged 40 to 45 and 50 to 55 years enrolled
in a randomized controlled trial to evaluate the efficacy of a tailored mammography
decision aid. Objective breast cancer risk was measured using the 5-year Gail
score. Subjective breast cancer risk was measured using perceptions of absolute
risk, perceptions of comparative risk, and worry about getting breast cancer.
At 12-month follow-up (November 2, 1998, to July 20, 1999), we measured interest
in taking a drug to prevent breast cancer.
Results Among the 1273 women surveyed, 23% were interested in taking a drug
to prevent breast cancer; 8% were potentially eligible for tamoxifen therapy
(5-year Gail score  1.66%). Eligibility for chemoprevention, based on the
5-year Gail score, was not associated with interest in taking a drug to prevent
breast cancer. Women who were worried about breast cancer were 3 times more
likely to be interested in taking a drug to prevent breast cancer than those
who were not worried.
Conclusion Women's interest in chemoprevention might arise more from worries about
getting breast cancer than from their objective risk factors.
INTRODUCTION
CHEMOPREVENTION is the use of pharmacologic or natural agents to inhibit
the development of cancer. Currently, tamoxifen citrate is the only approved
chemopreventive agent for breast cancer.1 Decision
making about chemoprevention for breast cancer is difficult and should require,
at minimum, identification of potential risks and benefits based on a woman's
profile of breast cancer risk factors.
Given the broad range of risk factors identified for breast cancer,
many women will have at least 1 risk factor. Although genetic breast cancer
refers to those cancers associated with BRCA1 or BRCA2 mutations, familial breast cancer represents a much
broader group of women at risk; approximately 8% of women in the general population
have at least 1 first-degree relative with breast cancer.2
Additional factors that modify breast cancer risk include current age, age
at menarche, nulliparity, age at first live birth, age at menopause, and benign
forms of breast disease.3 The Gail model provides
an overall summary score incorporating these risk factors.4-5
For women at elevated risk for breast cancer, there are several management
options: close surveillance with clinical breast examination and mammography,
prophylactic bilateral mastectomy or oophorectomy, and chemoprevention.6 The most recently available option is taking tamoxifen
for 5 years as a chemopreventive agent. Tamoxifen, the original selective
estrogen receptor modulator, has been used since the 1970s to treat localized
and metastatic estrogen-receptor–positive breast cancers. Its effect
as a chemopreventive agent was examined in 3 clinical trials.7-9
The US Breast Cancer Prevention Trial, sponsored by the National Surgical
Adjuvant Breast and Bowel Project,7 was the
largest of the 3 clinical trials and included more than 13 000 women.
Women were eligible for this study if they were (1) 60 years or older or (2)
were 35 years or older with a 5-year calculated risk (using the Gail model)
of at least 1.66% or a history of lobular carcinoma in situ. Tamoxifen treatment
was beneficial in all age groups and within all levels of breast cancer risk,
with a 49% reduction in the risk of invasive breast cancer. However, tamoxifen
treatment also increased the risk of endometrial cancer and thromboembolic
events compared with placebo at 47.7-month follow-up.7
Based on findings from the National Surgical Adjuvant Breast and Bowel
Project, the US Food and Drug Administration approved use of tamoxifen for
reduction of breast cancer risk in women at high risk, as defined by the Breast
Cancer Prevention Trial (ie, 5-year Gail score 1.66%). Since Food and
Drug Administration approval, pharmaceutical companies have begun direct marketing
to women, and the National Cancer Institute has developed a "risk disk" to
help women and their providers determine potential eligibility for breast
cancer chemoprevention. Many women might be interested in taking tamoxifen.
It is likely that women's initial impressions of this chemopreventive agent
will be based on their perceived susceptibility for breast cancer and not
on their actual risk factors.
Physicians might be unclear about when to consider chemoprevention for
breast cancer. They might not be able or have enough patient interaction time
to systematically determine which women are at high enough risk to consider
breast cancer chemoprevention and to conduct in-depth risk-benefit analyses
for those who have elevated risk and interest in chemoprevention. Therefore,
women can self-select for this therapy. In anticipation of such self-selection,
there is a need for data that will guide development of decision aids10-11 for breast cancer chemoprevention.
The goal of decision aids is to facilitate personal decisions about issues
for which we have not yet identified the best choices for reducing morbidity
and mortality. Taking tamoxifen for breast cancer chemoprevention is such
a choice, presenting potential benefits and risks. Before we can design decision
aids that facilitate decisions consistent with an individual's own situation,
preferences, and values, we need to understand more about factors associated
with an interest in chemoprevention.
To our knowledge, this is the first study to explore determinants of
interest in taking a chemopreventive agent for breast cancer. Because age
has important implications for the risk of breast cancer and the risks from
taking tamoxifen,4-5,7
we investigated 2 age groups (40-45 and 50-55 years). We hypothesized that
women with higher perceived breast cancer risks and worries would express
greater interest in chemoprevention for breast cancer.
PARTICIPANTS AND METHODS
PARTICIPANTS
Participants were selected at random from a list provided by Blue Cross/Blue
Shield of North Carolina. The sampling frame was stratified by age and mammography
status based on Blue Cross/Blue Shield claims data. We included women aged
40 to 44 and 50 to 54 years enrolled with the Personal Care Plan of Blue Cross/Blue
Shield. Because women aged during the study, some women in this analysis are
45 or 55 years old. About two thirds of the women were chosen because they
reported having a mammogram within the previous 1 to 2 years, depending on
their age. We excluded women with a previous diagnosis of breast cancer and
those who had more than 1 mammogram in a 12-month period during the designated
time frame.
A total of 2165 women were mailed a letter informing them of the study;
1287 (59%) consented and completed the telephone survey (Table 1); 337 (16%) refused to participate; 291 (13%) had incorrect
or disconnected telephone numbers; 158 (7%) were ineligible because they were
not Blue Cross/Blue Shield members at the time of the interview; 6 (0.3%)
were ineligible because they had breast cancer; 6 (0.3%) were ineligible because
of age; and 80 (4%) were never reached. After deleting those who were ineligible,
our completion rate for the baseline survey was 76%, and our refusal rate
was 20%. Women were surveyed by professional telephone interviewers from Battelle
Centers for Public Health Research and Evaluation (Durham, NC) at baseline
(November 3, 1997, to May 6, 1998) and at 12-month follow-up (November 2,
1998, to July 20, 1999).
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Table 1. Demographic Characteristics of the Baseline Sample, Stratified
by Age Group
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MEASURES
In addition to sociodemographic measures such as age, race or ethnicity,
marital status, educational level, and adequacy of income, we measured mammography
use, current smoking status, and hormone replacement therapy (HRT) use (see
Rimer et al12 for additional details). The
main measures are described in the following paragraphs.
Interest in Chemoprevention for Breast Cancer
We asked, "Are you interested in taking a drug to prevent breast cancer?"
as our main outcome measure. Response options were "interested," "not interested,"
and "don't know." We dichotomized responses to "interested" vs other responses,
for convenience termed "not interested."
Perceptions of Absolute Breast Cancer Risk
Absolute risk was assessed using standard verbal and numerical measures
within the span of 10 years. For the verbal measures, women were asked, "How
likely are you to get breast cancer in the next 10 years?" Responses were
"very unlikely," "unlikely," "50-50 chance," "likely," and "very likely."
For the numerical measures, women were asked, "On a scale from 0 to 100, with
0 indicating certain not to happen and 100 indicating certain to happen, how
likely are you to get breast cancer in the next 10 years?"
Perceptions of Comparative Breast Cancer Risk
We asked, "Compared with other women your age, how likely are you to
get breast cancer in the next 10 years?" Responses were "much below average,"
"below average," "same average risk as other women your age," "above average,"
and "much above average."
Worry About Getting Breast Cancer
We asked, "How worried are you about getting breast cancer in the next
10 years?" Responses were "not at all worried," "slightly worried," "somewhat
worried," "worried," and "very worried."
Assessment of Objective Breast Cancer Risk
We used the most recent Gail algorithm to assess objective breast cancer
risk.5 The Gail model calculates an absolute
risk score based on current age; race; age at menarche; mother or sisters
with breast cancer; age at first live birth; and number of breast biopsies,
including any with atypical hyperplasia. Using the National Surgical Adjuvant
Breast and Bowel Project clinical trial criteria,7
we dichotomized the 5-year Gail score, using a Gail score of 1.66% or greater
(elevated breast cancer risk) vs less than 1.66% (nonelevated breast cancer
risk).5
Depression
Because we hypothesized that depression would affect risk perceptions,
we used the abbreviated 10-item Center for Epidemiological Studies–Depression
scale to measure depression and considered a score of 10 or more as identifying
significant depressive symptoms.13
STATISTICAL ANALYSIS
We first assessed whether the Gail score's objective measure of breast
cancer risk was related to perceived breast cancer risk and worry. Stratifying
our analyses by age groups (40-45 and 50-55 years), Pearson  2
and t statistics were used to compare differences
between women interested and not interested in taking a drug to prevent breast
cancer on demographic characteristics, health behaviors, depression, perceived
risk for breast cancer, and 5-year Gail score. The analyses for this study
are based on 1273 women who completed the 12-month follow-up survey. We used
logistic regression to model the probability of interest in chemoprevention
for breast cancer. Because we hypothesized that perceived risk and worry for
breast cancer, and not actual risk, would be related to interest in taking
tamoxifen, we included these as main effects in the model. We used comparative
risk in the logistic regression model because other authors14
determined that it is a good measure of perceived susceptibility. Age group
(40-45 vs 50-55 years), education, depression, smoking, and HRT use were associated
with an interest in chemoprevention in bivariate analyses (P<.10) and were included in the logistic regression model as covariates.
RESULTS
CORRELATION OF OBJECTIVE RISK, PERCEIVED RISK, AND WORRY FOR BREAST
CANCER
Overall, greater objective risk (as measured by the 5-year Gail score)
was associated with greater perceived absolute risk (measured numerically
on a scale from 0-100), greater perceived comparative risk, and greater worry
(Table 2). Spearman correlation
coefficients were less than 0.2.
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Table 2. Correlations Among Objective Risk and Perceptions of Risk
and Worry for Breast Cancer, Stratified by Age Group*
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POTENTIAL ELIGIBILITY FOR TAMOXIFEN THERAPY
In the entire cohort of women in this community-based sample, 8% had
a 5-year Gail score of at least 1.66%. In the younger age group (40-45 years),
3% of women met criteria for high risk, and 12% in the older age group (50-55
years) were considered to be at high risk.
INTEREST IN CHEMOPREVENTION FOR BREAST CANCER
Overall, 23% of women were interested in taking a drug to prevent breast
cancer (21% of those aged 40 to 45 years and 24% of those aged 50 to 55 years)
(Table 3). Women interested in
chemoprevention in the younger age group believed themselves to be at greater
risk for breast cancer (measured numerically and compared with other women)
and were more worried about breast cancer (P<.01).
Women interested in taking a drug to prevent breast cancer also exhibited
more depressive symptoms and were more likely to smoke (P<.01). However, the 5-year Gail score was not associated with interest
in chemoprevention.
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Table 3. Level of Interest in Chemoprevention for Breast Cancer Among
Women, Stratified by Age Group*
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As in the younger age group, those aged 50 to 55 years who were interested
in chemoprevention believed themselves to be at greater breast cancer risk
(measured numerically and compared with other women) and were more worried
about breast cancer (P<.05). Objective breast
cancer risk (5-year Gail score 1.66% or <1.66%) was not associated
with an interest in chemoprevention for this age group either.
In logistic regression analyses of the combined age groups, worry about
breast cancer, comparative risk of breast cancer, current smoking status,
and HRT use were significantly associated with an interest in chemoprevention
(Table 4). There was a trend for
women with depressive symptoms to be more interested in chemoprevention for
breast cancer (P = .07).
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Table 4. Logistic Regression Analysis Modeling Interest in Chemoprevention
for Breast Cancer as the Outcome Variable*
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COMMENT
To our knowledge, this is the first study to examine interest in chemoprevention
for breast cancer and identify determinants of this interest. Although this
was a predominantly low-risk community-based sample (only 8% had 5-year Gail
scores 1.66%), more than 20% expressed interest in taking a drug to prevent
breast cancer. Given the new indication for tamoxifen as a breast cancer chemoprevention
agent in high-risk women, the publicity tamoxifen is receiving, and the interest
expressed in our sample, health care providers should initiate discussions
about this controversial and complicated medical decision with their patients.
Our research suggests that patients' interest in chemoprevention for breast
cancer might arise more from worries about getting breast cancer than from
their objective risk factors. Thus, putting patients' breast cancer risks
in perspective should be part of the process of facilitating informed decision
making about chemoprevention. Of course, we recognize that we assessed interest
only, and it is likely that many women who expressed an interest would have
subsequently declined to take tamoxifen when informed fully about the risks
and benefits.
Although the incidence of breast cancer increases with age, previous
studies15 have found that younger women disproportionately
overestimate their risk of breast cancer. Whereas the average woman in her
early 40s has a 1-in-200 chance of developing breast cancer in 5 years, and
this risk increases to only 1-in-100 for the average woman in her early 50s,
many women in these age ranges think that their risk is closer to 1 in 10.16 In our community sample, the average perceived absolute
risk was 30%, or a 1-in-3 chance of developing breast cancer in 10 years.
Women in their early 40s and 50s similarly overestimate their risk of breast
cancer. Clearly, women should base their decisions about chemoprevention or
other preventive strategies not on their perceived susceptibility but on the
best objective risk measures. This means that any educational efforts must
include information about cancer risk.
Independent of perceived susceptibility, we found that women who worried
about breast cancer were 3 times more likely to be interested in breast cancer
chemoprevention than their less-worried counterparts. Although one might speculate
that worry leads to anxiety, which has the potential to inhibit behavior,
several studies17-19
have shown that the same worry can have a positive effect on health behaviors.
In our analyses, worry about breast cancer was minimally correlated with objective
risk (correlation coefficients, 0.12 [ages 40-45] and 0.17 [ages 50-55]).
These findings suggest that physicians who discuss breast cancer chemoprevention
with their patients might need to reassure those who are worried about breast
cancer by facilitating more realistic risk perceptions. There is substantial
confusion about breast cancer and breast cancer risk; continuing efforts are
needed to overcome misperceptions.12
Current smokers were 90% more likely to be interested in chemoprevention
than nonsmokers. Although a clear and strong causal relationship between smoking
cigarettes and breast cancer risk has yet to be established,20
women who smoke might perceive their risk for all cancers to be greater. Women
who smoke are at greater risk for thromboembolic events such as deep vein
thrombosis and pulmonary embolus; however, smokers might be at reduced risk
for endometrial cancer.5 A woman's current
smoking status should be addressed when discussing potential benefits and
risks associated with breast cancer chemoprevention, specifically tamoxifen
therapy because there is an increased risk of endometrial cancer and thromboembolic
events among women who take tamoxifen.
Current HRT use was also associated with an interest in chemoprevention
for breast cancer. This increase in interest for chemoprevention among women
using HRT might reflect their willingness to take medications, including hormones,
or concern that their breast cancer risk is higher because of hormone use.
Current guidelines for breast cancer chemoprevention recommend discontinuing
HRT before starting tamoxifen therapy.5 Part
of the decision-making process requires that women decide whether to discontinue
HRT to take tamoxifen. If so, women who are taking HRT for climacteric symptom
relief will likely experience a return of these unwanted symptoms, such as
hot flushes and night sweats, which might be exacerbated by tamoxifen use.21
Women who reported clinically important depression symptoms were more
interested than other women in taking a drug to prevent breast cancer, independent
of worry about breast cancer (P = .07). These findings
suggest that physicians might need to evaluate women for clinical depression
when discussing breast cancer chemoprevention. The prevalence of depressive
symptoms in this community sample of women was higher than reported in the
general population. This high prevalence of depressive symptoms was noted
in a similar community sample of women (aged 45-54 years) and could be attributed
to the overlap between depression and climacteric symptoms, which are both
measured using the abbreviated Center for Epidemiological Studies–Depression
scale.22
An informed decision to use tamoxifen for chemoprevention would require
a thorough risk-and-benefit analysis. Although tamoxifen has protective antiestrogenic
effects on the breast, its other estrogenic effects can be harmful, although
these are estimated to be very low. For example, through its estrogenic effect
on the uterus, tamoxifen can increase the risk of endometrial cancer, depending
on age and menopausal status.7 On the other
hand, tamoxifen can decrease cholesterol levels and increase bone density
in postmenopausal women.7 Tamoxifen can also
increase the risk of stroke, pulmonary embolism, and deep vein thrombosis.7 In addition, use of tamoxifen has been associated
with a decrease in bone density among premenopausal women,23
worsening climacteric symptoms in postmenopausal women,24-25
and an increase in the incidence of depression.25-26
Results of this study should be considered in light of a few limitations.
First, interest in taking a drug to prevent breast cancer was measured by
self-report and was not assessed behaviorally. Our estimates are likely much
higher than if we assessed rates of tamoxifen prescriptions for chemoprevention.
Second, hysterectomy status was not examined and might be a potential factor
related to interest in chemoprevention because women without a uterus do not
have to consider the potential risk of endometrial cancer associated with
tamoxifen use. Third, we used only single-item measures to assess perceptions
of breast cancer risk and worry. Although age is the most important risk factor
for breast cancer, in this study we addressed interest in chemoprevention
of women in their early 40s and 50s. Further research is needed to explore
interest in using chemoprevention for breast cancer among women aged 60 years
and older. Finally, because the major purpose of our study was to obtain data
about mammography use, we could not collect in-depth information about correlates
of tamoxifen use that would have been ideal.
Many women in their 40s and 50s say that they are interested in breast
cancer chemoprevention despite the fact that for most of them, consideration
of tamoxifen therapy seems completely unwarranted. This unwarranted interest
in chemoprevention might stem from their overestimation of breast cancer risk.
Women need help assessing their breast cancer risks and risk-reducing options
and weighing the risks and benefits of taking tamoxifen. Physicians might
need guidance about how to counsel patients about breast cancer risk and assessing
the appropriateness of tamoxifen treatment. Decision aids for breast cancer
chemoprevention are needed to maximize the scarce time of health care professionals.27 Such decision aids should address breast cancer risks,
perceptions of risk and worry about breast cancer, HRT use, and smoking status
and should take into account additional risk factors for endometrial cancer,
thromboembolic events, and depression. Ultimately, there are no right or wrong
answers for most patients. The goal should be to help individuals decide what
is best for them.
AUTHOR INFORMATION
Accepted for publication December 13, 2000.
This work was supported in part by grant CA72099 and Veterans Affairs
Career Development Award from the Health Services Research and Development
Service, Washington, DC (Dr Bastian).
Presented as an abstract at the annual meeting of Veterans Affairs Health
Services Research and Development, Washington, DC, March 23, 2000.
The views expressed in this article are those of the authors and do
not necessarily represent the views of the Department of Veterans Affairs.
Corresponding author and reprints: Lori A. Bastian, MD, MPH, The
Center for Health Services Research in Primary Care, Durham Veterans Affairs
Medical Center, 508 Fulton St (152), Durham, NC 27705.
From Cancer Prevention, Detection, and Control Research (Drs Bastian,
Lipkus, Kuchibhatla, Halabi, Skinner, and Rimer) and the Departments of Internal
Medicine (Drs Bastian and Ryan), Family and Community Medicine (Drs Lipkus,
Kuchibhatla, Halabi, and Rimer), and Surgery (Dr Skinner), Duke University
Medical Center, Durham, NC; The Center for Health Services Research in Primary
Care, Durham Veterans Affairs Medical Center (Dr Bastian and Ms Weng); and
Division of Cancer Control and Population Sciences, National Cancer Institute,
Bethesda, Md (Dr Rimer).
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