Treatment Decisions and Breast Cancer: Psychosocial Outcomes
Conditions: Breast Cancer
Sponsor: M.D. Anderson Cancer Center

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Treatment Decisions and Breast Cancer:  Psychosocial Outcomes 
Protocol 2013-0752 
NCT02263014 

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1.0  
OBJECTIVES 
          Breast cancer is the most common cancer for women in the U. S. and an estimated 
232,340 women will be diagnosed in 2013.1 After diagnosis, women and their physicians 
must consider many treatment-related decisions which are often made quickly while 
women are still adjusting to the news of their diagnosis. For women with unilateral breast 
cancer, another option is the removal of the cancer-free breast (contralateral prophylactic 
mastectomy, CPM).  In our research, more than 59% of women with breast cancer have 
initial interest in CPM; thus, this is an issue that affects the majority of women with 
breast cancer.  The use of CPM in patients with sporadic unilateral invasive breast cancer 
increased by 150% from 1993 to 2003 and its use continues to increase.2,3 While CPM 
reduces the risk of developing a contralateral breast cancer, there is no evidence that it 
reduces breast cancer mortality or overall death.4 Women with early stage sporadic breast 
cancer have a 0.5 to 0.75% annual risk of developing contralateral breast cancer5-8 and for 
most, the risk of distant metastatic disease is greater than the risk of developing a 
contralateral breast cancer.  Despite evidence that adjuvant endocrine therapy reduces the 
risk of contralateral breast cancer,9-11 an increasing number of women choose CPM; 
however, the outcomes of these patients are not well understood. Much of our knowledge 
about prophylactic mastectomy is from studies of high risk women who have a 40-65% 
lifetime risk of developing breast cancer12,13 and represent less than 10% of breast cancer 
patients. Thus, little information is available to help average risk women make this 
important and irreversible healthcare decision. This study will provide the data critical to 
inform women about the likely psychosocial outcomes if they undergo CPM or receive 
standard of care (no CPM). We expect the results will improve patients’ understanding of 
the benefits and risks of CPM and guide the development of evidence-based practices to 
enhance the individualized treatment decision-making process. 
 
     Specific aim is to:  
1)  To prospectively examine the psychosocial outcomes of women with sporadic breast 
cancer who have CPM versus those who do not. We will also determine the impact of 
patient and physician characteristics on the outcomes. We hypothesize that women who 
have CPM will have more decisional regret (the primary outcome), cancer-specific 
distress, cancer worry, and fear of recurrence and lower satisfaction with their decision 
than those who do not have CPM. 
 
2.0 BACKGROUND AND RATIONALE 
     Breast cancer is the leading cause of cancer among women in the U.S., affecting 
approximately 226,870 women annually.14  The majority of patients (93%) are diagnosed 
with operable disease and undergo surgical management of the affected breast with either 
breast conserving surgery or mastectomy.15  It is well recognized that adjuvant systemic 
chemotherapy has substantially reduced the probability of dying from breast cancer.16  
Among women with hormone-positive breast cancers, adjuvant treatment with tamoxifen 
or aromatase inhibitors reduces the risk of developing a contralateral breast cancer by 

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approximately 50%.9  In fact, it is estimated that the combination of mammography 
screening and adjuvant systemic therapies have contributed to a 30% overall reduction in 
breast cancer mortality over the past decade.17   
     Despite these major achievements over the past two decades in reducing breast cancer 
mortality through evidence-based practices, there has been a rising incidence of CPM. 
The combined annual rate of CPM (~8%) in population-based studies of women with 
invasive breast cancer or ductal carcinoma in situ2,3 translates into over 18,000 potentially 
over-treated patients based on an expected 226,870 new breast cancer cases in 2013.14  
Rates of CPM are even higher in academic medical centers and were estimated to be 
between 14-28% from 2006 to 2007.18-20 These higher than average annual rates of CPM 
at centers that offer multidisciplinary care may reflect an increasing trend in the numbers 
of patients with sporadic breast cancer electing to undergo CPM and the availability of 
plastic surgery expertise for reconstruction.  Our previous studies with breast cancer 
patients suggest that, before meeting with their surgeon, 59% of women indicated they 
had at least some interest in CPM.  Hawley et al. reported in a population-based survey of 
women from Detroit and Los Angeles that among women undergoing a mastectomy of 
their affected breast, 53% said that they considered CPM.21  Thus, the topic of this 
proposal affects the majority of women with stage I-III breast cancer.   
     Patients perceive that CPM with reconstruction is associated with a reduced risk of 
surgical complication because it is the removal of a healthy breast.22  However, in 
addition to increased medical cost, CPM with reconstruction has surgical morbidity.  
Several studies have shown surgical reoperations are common among women who 
receive prophylactic mastectomy and reconstruction.23-25  Frost et al reported that 27% of 
women had at least one unanticipated reoperation after CPM24 and Barton et al26 and 
Crosby et al22 reported that 27% to 66% of women had at least one complication.  This 
means that at least one-third of patients might not have experienced a surgical 
complication if they had they had not chosen CPM. The reason for the increasing 
incidence of CPM at a time when medical advancements have significantly improved the 
lives of women with early-stage breast cancer is poorly understood yet has a profound 
impact on patient surgical morbidity, the economic burden of cancer treatment and cancer 
survivorship.  
       Previous research that has examined decision making about women’s choice of 
mastectomy or breast conservation therapy for treatment of early-stage breast cancer has 
found that multiple factors influence women’s surgical decisions including demographic 
characteristics (e.g., age, race, marital status) and women’s own perceptions and values.27  
Physicians have also been found to influence surgical decision making.28  For women 
who are at high genetic risk for cancer, readiness to engage in genetic testing was 
associated with perceptions that the benefits outweigh the risks29 and research suggests 
that medical, psychological and social context factors affect women’s decision making.30 
Anxiety and worry, for example, have been associated with BRCA testing and 
management decisions.31 Research has also found that, among those who prefer to be 
involved, shared decision making is associated with better psychosocial adjustment.32-34  
The current proposal includes these factors as well as other variables that are 
hypothesized to influence decision making about CPM.   
      Another important gap in knowledge is how CPM for women with unilateral sporadic 
breast cancer affects their psychosocial adjustment following surgery.  This information 

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is essential to provide women and their physicians with guidance about making the 
decision to have CPM. The studies that have been conducted to date have been primarily 
retrospective35-38 and they have included women with breast cancer who are at higher risk 
of contralateral breast cancer (e.g., BRCA 1/2 mutation carriers).39,40  In addition, the lack 
of a control group in these studies limits our ability to ascertain whether CPM is 
associated with better or worse psychosocial outcomes.36,37,41,42  Frost et al42 
retrospectively collected data on a cohort of women who had CPM from 1960 to 1993.  
The first questionnaire was administered on average 10.7 years and the second one 20.2 
years after receiving CPM.  In this retrospective study, 90% of women were satisfied or 
very satisfied with their decision.  Women who were dissatisfied reported adverse body 
image and adverse symptoms or complications.42  Forty-four percent of the sample 
reported adverse effects of CPM for one or more social or psychological domains.  Most 
adversely affected were body appearance, feelings of femininity, and sexual 
relationships.  Importantly, all women in this cohort had a family history of breast cancer 
and therefore the findings may not reflect the experiences of average risk breast cancer 
patients.  Nonetheless, prior research suggests that a proportion of women who undergo 
CPM experienced decreased satisfaction with appearance despite overall high satisfaction 
with their decision.37,38 It is not known whether the outcomes of average-risk women 
would be similar or not.  Given that their risk of contralateral breast cancer is lower and 
for women with estrogen receptor (ER)-positive disease there are alternative approaches 
to further reduce risk (e.g., taking tamoxifen or aromatase inhibitors), there is reason to 
believe that their experiences may be quite different.  Rolnick et al43 examined what 
women wished they had known before prophylactic surgery (both women who had CPM 
and women who had bilateral prophylactic mastectomy) and found that more than 58% of 
women wished they had more information before having CPM.43  Specific areas of 
reported insufficient information were about reconstruction and implants and 
complications such as pain, scarring and numbness.  Women also reported wishing they 
had more information about the potential for negative emotions following surgery. These 
results suggest areas of concerns of women with unilateral sporadic breast cancer 
following CPM, but a prospective, comprehensive study is needed in order to examine 
these issues in average risk women. 
 
 
3.0 RESEARCH DESIGN AND PROCEDURES 
 
 
Study Population. Patients will include women seen at MDACC (n=245) or K-S (n=100) 
who meet the following inclusion criteria: ductal carcinoma in situ (DCIS) or Stage I-III 
newly diagnosed sporadic unilateral invasive breast cancer; over age 18; and able to 
speak, read, and write in English.  Patients with previous breast cancer, prior history of 
prophylactic mastectomy or are known to have a germline gene mutation that predisposes 
them to an increased risk of breast cancer (e.g., BRCA1, BRCA2), and/or if they are 
considered at high risk for contralateral breast cancer on the basis of a strong family 
history of cancer will be excluded.44  Based on our estimates over the past 5 years and the 
data from our completed R21 study, we expect that at least 10-15% of women who come 
for surgical treatment for ductal carcinoma in situ (DCIS) or Stage I-III unilateral breast 

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cancer will opt for CPM.  Thus, for patients approached at their initial surgical consult 
appointment, we will screen all eligible patients during the 27-month recruitment period 
for initial interest in CPM (see section below) at the time of recruitment to identify 
women who are and who are not initially considering CPM. Spouse/partner eligibility:  
married or living with partner for at least 1 year, 18 years or older, able to speak, read and 
write in English.   
 
Study Procedures. 
 
After completing the initial set of questions (patient information/demographics questions 
for all patients and screening questions for patients seen at initial surgical consult), 
patients who consent to the study will be given questionnaires to complete at five time 
points:  baseline (around the time of study enrollment), and approximately 1, 6, 12, and 
18 months following their surgery for breast cancer.  For participants who prefer to 
complete the study survey(s) electronically, participants may complete on-line versions 
of the same survey(s) using REDCap (Research Electronic Data Capture).   
Participants will receive a $20 gift card after completing the study questionnaire 
at each time point to compensate them for their time and effort.  They can receive up to 
$100 in gift cards if they complete questionnaires at all 5 time points.  Parking 
reimbursement will be provided for patients and spouses participating in the optional 
interview if he/she opts for an in-person interview at MD Anderson. 
 
Study Measures.   The domains chosen for study measures are based on the Integrated 
Model of Behavior45,46 and Ottawa Decision Framework47 as well as results of our R21 
study of decision-making and CPM.  
 
     Background Information.  Participant will complete demographic information (i.e., 
age, race, ethnicity, marital status, education, and occupation).  Medical variables (i.e., 
date of breast cancer diagnosis, method of detection, tumor histology, nuclear grade, 
stage, human epidermal growth factor receptor (HER2/neu), estrogen receptor (ER) and 
progesterone receptor (PR) status, and weight and height at diagnosis) will be extracted 
from patients’ charts.   
     Cancer-Specific Distress. Cancer-specific distress will be measured with the Revised 
Impact of Events Scale (IES).  The IES assesses two common categories of responses to 
stressful events:  intrusion and avoidance. The IES has good internal consistency 
reliability (0.70 to 0.85).48  For this study, patients will be asked to rate the frequency of 
intrusive thoughts and avoidance behaviors related to their cancer.48,49   
     Breast Cancer Worry Scale. Breast cancer worry will be assessed with a 4-item scale 
developed by Lerman et al.49,50  These items assess the extent to which worry about 
breast cancer interferes with women’s daily functioning.  
     Fear of Cancer Recurrence.  Fear of recurrence will be assessed with a 5-item 
scale that measures patients’ beliefs and anxieties about disease recurrence.51,52  It 
has been used with a variety of cancer populations and the psychometric 
properties of this measure have been well-established.53,54  
      Satisfaction with Decision Scale.  A measure of women’s satisfaction with 
their surgery decision.55  It has been used with a variety of healthcare decisions 

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and has been shown to have good reliability and validity.55  It will be 
administered at 1, 6, 12 and 18 months post-surgery.   
     Decisional Regret. This brief scale measures distress or remorse about the 
surgical decision.56  It has been used to assess regret with a variety of healthcare 
decisions and has been shown to be reliable and valid.56   It will be administered 
at 1,6,12 and 18 month assessments. 
     
4.0 Statistical Considerations. 
 
Analytic Methods: 
General:  Our first steps will be to summarize patients’ baseline demographic, risk 
behavior, and disease-related information using descriptive statistics. This will include 
means, standard deviations, medians and ranges for continuous variables and frequencies 
and percentages for categorical responses.  Descriptive statistics will be summarized 
separately for each group and for each group over time for psychosocial variables. 
Groups of women will include women who have had CPM and those who have not had 
CPM.  For women for whom we have information on their initial interest in CPM, the 
latter category of women also being categorized by those who initially had an interest in 
CPM versus those who did not have an interest in CPM. We will compare information 
about these groups of women for continuous variables using t-tests, analyses of variance 
(or their nonparametric equivalents such as Wilcoxon rank sum tests) or for categorical 
variables chi-square tests or Fisher’s Exact tests. Group comparisons tested for 
significance will include the two primary groups of CPM versus no CPM and also for the 
women for whom we have information on their initial interest in CPM, the three 
following groups: initial interest and had CPM, initial interest but did not have CPM, and 
no interest and did not have CPM.  
     Our initial primary analyses for each psychosocial variable will evaluate women’s 
psychosocial outcomes over time using a general linear model (PROC GLM in Statistical 
Analysis Software (SAS)) incorporating information over time (baseline and 1, 6, 12, and 
18 months post-surgery) with the psychosocial variable being the dependent variable and 
whether or not the women had CPM the independent variable. We will determine if the 
psychosocial variable (on average) differs between the groups, if there are differences 
over time (averaged over groups), and whether or not these differences of time are 
different for different groups (a group by time interaction).  Analyses will be made in 
SAS version 9.3 (SAS Institute Inc., Cary, NC, USA).  
 
     Missing Data. Because we are using patient-reported outcomes, some individuals will 
fail to complete all questionnaires.  PROC GLM in SAS is designed to handle this type of 
missing data and will give unbiased estimates of effects over time provided that the 
probability of having missing data depends only on the covariates in the model.  We will 
check this assumption by looking at predictors of missing data. We will also run analyses 
to examine whether study participants who drop out of the study early differ from those 
who do not. With the use of PROC GLM, we will be able to include all participants in the 
analysis, even those with missing values for some time points and those who drop out 
early. We will also use alternative multiple imputation methods to estimate missing 
values using differing assumptions if the data appear to not be missing at random. Several 

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0.0
0.1
0.2
0.3
0.2
0.4
0.6
0.8
1.0
Treatment Effect Power vs Effect S
Effect Size on Treatment
Treatment Effect Power
r = 0.3
r = 0.5
r = 0.7
strategies will be used to decrease the chance of missing data and non-compliance. Forms 
will be reviewed upon receipt to ensure all items are completed, and if incomplete, 
participants will be contacted to determine if the question was deliberately skipped and, if 
not, to get a response. Patients will be contacted numerous times by mail and by phone to 
ensure questionnaire completion.  Scheduling of follow-up visits will coincide with clinic 
visits, and as such, missing data will be kept at a minimum.  
     
 
 
Sample size:  Given information from the recently 
completed R21 study and rates over the past 5 years, we 
estimate that approximately 11.5% of women meeting 
eligibility criteria will have CPM. All power analyses 
assume a significance level of 0.05 and a two-sided 
test. Assuming a 10% attrition rate and an additional 
loss of 10% of patients due to eligibility changes post-
enrollment, we will enroll approximately 345 
participants to ensure that approximately 311 
participants continue on study to yield complete data on 
at least 280 participants. Therefore, about 32 women will 
have CPM, and 248 will not.  For comparisons of these two 
groups of women, a sample size of 280 (32 in the CPM group and 248 
in the non CPM group) at 18 months post-surgery will provide 80% power to detect an 
effect size of 0.54 or greater for the continuous dependent variables. 
     Since the primary psychosocial outcomes (such as decisional regret distress and scale) 
include repeated measurements that are correlated within subjects, our approach will 
utilize linear mixed model analysis 
(LMM, a special case of generalized 
linear mixed modeling in which each 
outcome variable is continuous). For the 
LMM analyses of continuous dependent 
variables across time (baseline, 1, 6, 12, 
and 18 months post-surgery), we 
calculated detectable effects based on a 
wide range of homogeneous correlations, namely, 0.3, 0.5, and 0.7, between repeated 
measurements. To simplify the power calculation procedure, we assume that there is no 
interaction between treatment and time points. The detectable effects of treatment are 
presented in Table 3. The calculations were done using PASS 2005 (Power Analysis and 
Sample Size Software). We provide a brief explanation of the results presented in the first 
row. In the first row, the homogeneous correlation between treatments across time points 
is assumed to be 0.3.  A sample size of 259 (32 in the CPM group and 227 in the non 
CPM group) will provide 80% power to detect a standard deviation (SD) in means across 
groups of 0.10 (an effect size of 0.19), which corresponds to the means of 0, 0.290 (in SD 
unit) in the two groups. The above figure provides the power plot by effect size on 
treatment when the correlations (r) are 0.3, 0.5, and 0.7, respectively.       
   
 

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