What was the research about?
Most women with cancer in one breast have a low risk of getting cancer in their other breast. But many women choose to have both breasts removed to prevent future breast cancers. Surgery to remove the healthy breast is called contralateral prophylactic mastectomy (CPM).
Researchers wanted to see how CPM affects a patient’s mental and social well-being. The research team compared two groups: patients who had both breasts removed and patients who had part or all of the breast with cancer removed but kept their healthy breast.
What were the results?
Compared with patients who kept the healthy breast, patients who had CPM had
- More stress and suffering from their cancer before and after CPM
- More concerns about body image before and after CPM
- More worry about their cancer before CPM
- The same amount of worry about their cancer after CPM
- The same quality of life before CPM
- A lower quality of life after CPM
Patients’ satisfaction with their treatment choice was the same for patients who had CPM and those who kept their healthy breast.
In interviews, patients said they worried about getting cancer again no matter which treatment they chose. Patients who had CPM said having both breasts removed gave them peace of mind.
A computer program predicted that CPM would have little effect on how long patients lived.
Who was in the study?
The study included 252 women from a cancer center and a community clinic in Houston, Texas. The patients were newly diagnosed with cancer in one breast. The cancer was not inherited. Among the patients, 55.5 percent had part of the breast with cancer removed, 27 percent had the whole breast with cancer removed, and 17.5 percent had both breasts removed (CPM). The average patient age was 56. Most patients in the study were white (57 percent), followed by African American (15 percent), Hispanic (15 percent), and other (8 percent).
What did the research team do?
The research team asked patients to fill out surveys before surgery and then again 1 month, 6 months, and 12 months after surgery. Patients rated their stress and suffering, body image concerns, worry about cancer, quality of life, and happiness with their treatment choice. The team used the survey results to find out how CPM and other treatments affected patients’ mental and social well-being over time. The research team also interviewed 20 of the patients about how their breast cancer diagnosis and treatment choice affected their lives.
The research team made a computer program to estimate survival rates in patients with cancer in one breast. The program used results from published studies to make estimates. The program considered the age at diagnosis, extent of the cancer, and history of breast cancer in the family.
What were the limits of the study?
Some patients didn’t fill out all the surveys. The results may not have been the same if the mental and social well-being of patients who didn’t fill out all the surveys was different from those who filled out all the surveys. The study was done in one large city; results may differ in smaller cities or rural areas. The research team recruited some patients after they were diagnosed with breast cancer but before they saw a surgeon. The team recruited the rest of the patients after they had seen a surgeon. These differences in recruiting may have affected the patients’ survey answers.
Future studies could look for ways to improve patients’ well-being after treatment for cancer in one breast. Studies could also test ways to tell doctors and patients about how treatments may affect mental and social well-being.
How can people use the results?
Women with breast cancer and their doctors can use the results of this study when deciding on treatment for cancer in one breast.
To compare psychosocial outcomes and long-term survival estimates in women with nonhereditary unilateral ductal carcinoma in situ (DCIS) or breast cancer who underwent contralateral prophylactic mastectomy (CPM) versus women who underwent segmental or unilateral mastectomy
|Study Design||Observational: cohort study|
|Population||252 women ages 18 or older with newly diagnosed nonhereditary unilateral ductal carcinoma in situ or stage I, II, or III breast cancer|
Primary: psychosocial outcomes (i.e., quality of life, body image concerns, cancer worry, cancer distress, satisfaction with treatment decision)
Secondary: estimated overall survival, estimated quality-adjusted life years
|Timeframe||12-month follow-up for primary outcomes|
This mixed-methods prospective cohort study compared psychosocial outcomes in women with unilateral DCIS or breast cancer who underwent CPM versus women who underwent segmental or unilateral mastectomy. The study included 252 newly diagnosed women recruited over three years from an academic hospital and a community practice in Houston, Texas. Among these women, 55.5 percent underwent segmental mastectomy, 27 percent underwent unilateral mastectomy, and 17.5 percent underwent CPM. The mean patient age was 56. Approximately 57 percent of patients were non-Hispanic white, 15 percent were African American, 15 percent were Hispanic, and 8 percent were other.
Researchers used several validated questionnaires to assess psychosocial factors, including cancer distress, cancer worry, body image concerns, quality of life, and satisfaction with treatment decision. Patients completed questionnaires before surgery and again approximately 1, 6, and 12 months after surgery. The research team examined the effect of each treatment on social and mental well-being.
Researchers also interviewed 20 study patients about surgical decision making, diagnosis, and treatment for unilateral DCIS and breast cancer. Researchers linked the quantitative questionnaire data with the interview data to identify patterns in treatment choice.
The research team also developed a computerized decision model to estimate overall survival and quality-adjusted life years in women treated for nonhereditary unilateral DCIS or breast cancer. The model used data from health databases and previous studies to generate estimates. The model included each patient’s age at diagnosis, disease stage, estrogen receptor status, and family history of breast cancer.
The results showed an association between the decision to undergo CPM and several patient characteristics. The decision to undergo CPM was associated with Hispanic ethnicity (p < 0.01), higher cancer worry (p = 0.01), increased body image concerns (p < 0.01), and higher quality of life (p = 0.04).
After researchers accounted for collecting data from the same patient multiple times, they found that women who underwent CPM had higher levels of cancer distress (p = 0.03) and more body image concerns (p < 0.01) than women who did not undergo CPM. There was no statistically significant difference between groups for satisfaction with treatment decision.
Compared with women who did not undergo CPM, women who underwent CPM had
- Significantly higher cancer distress before surgery (p = 0.04) and 6 months (p = 0.03) and 12 months (p = 0.01) after surgery
- Significantly higher cancer worry before surgery (p < 0.01) but lower cancer worry 1 month after surgery (p < 0.01); no significant differences were observed 6 months and 12 months after surgery
- Significantly more body image concerns before surgery (p < 0.01) and 1 month (p < 0.001), 6 months (p < 0.001), and 12 months (p < 0.001) after surgery.
- Significantly lower quality of life 1 month (p < 0.01), 6 months (p = 0.05), and 12 months (p = 0.01) after surgery; no difference was observed before surgery
When interviewed, all women identified dealing with uncertainty, cancer worry, and concerns about recurrence as reasons for their treatment choice. Although study participants knew they had a low risk of developing new DCIS or breast cancer regardless of treatment choice, the women who chose CPM felt that their choice gave them peace of mind.
According to the decision model, women aged 40 years who had estrogen receptor-negative, stage I breast cancer and a first-degree relative with breast cancer tended to have a positive benefit with CPM based on estimated quality-adjusted life years. CPM had a minimal effect on estimated overall survival and a minimal or unfavorable effect on estimated quality-adjusted life years for women aged 50 years or older regardless of breast cancer stage or family history of breast cancer.
At each time point, approximately 20 percent of participants did not complete questionnaires. Results may have been different if the participants who did not complete questionnaires at every time point had different psychosocial experiences than those who completed all the questionnaires. The study was conducted in one large US city; results may differ in other areas. The academic center and the community center used different recruitment strategies, which may have affected the study sample and the study outcomes. The academic center recruited patients after diagnosis but before surgical consultation, while the community center recruited patients after both diagnosis and surgical consultation. Because the demographics of physicians participating in the study were similar, the researchers could not identify any physician-level factors that affected patients’ psychosocial outcomes. There were baseline differences in psychosocial variables between women who underwent CPM and those who did not; thus, causal inferences from the results of this study require caution.
Conclusions and Relevance
Women with nonhereditary unilateral DCIS or breast cancer who underwent CPM had less cancer worry one month after surgery compared with women who did not undergo CPM. Their body image concerns were no worse than those of women who did not have CPM. However, they had lower quality of life, and cancer distress was no better than that of women who did not have CPM. The computer model predicted that patients who underwent CPM were unlikely to survive longer than those who underwent a different treatment. Understanding the psychosocial impact and long-term survival outcomes of treatment strategies for unilateral DCIS or breast cancer may help physicians and patients engage in shared decision making.
Future Research Needs
Future research could investigate whether using conceptual or theoretical models might further illustrate how CPM affects patients’ psychosocial adjustment. Research could also provide information about how to use these findings in decision making.
Final Research Report
View this project's final research report.
Article Highlight: Women with nonhereditary breast cancer who opted to have a contralateral prophylactic mastectomy (CPM) experienced higher levels of precancer surgery worry, compared with women who did not have the prophylactic surgery, according to researchers in this study. In a recent Journal of Clinical Oncology report the researchers noted, however, that postsurgery worry diminished over time and was similar to that of women who did not have a CPM. The researchers suggest that physicians might consider discussing pre- and postsurgery worry with their patients, which can be a key factor in decisions about whether to have a CPM. The study surveyed 288 women, including 50 who had CPM, and 238 who had a unilateral mastectomy or breast conserving surgery.
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Peer review of PCORI-funded research helps ensure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.
Peer reviewers point out where the draft report may need to be revised. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer review process here.
In response to peer review, the PI made changes including
- Providing additional information about how the investigators developed the model on which decision analyses were based
- Explaining that the variables in Aim 1 came from previous literature rather than a conceptual or theoretical framework. No such framework drove the research, so the study may be missing important ways that women with breast cancer differ from those without breast cancer
- Updating the limitations section to acknowledge the lack of theoretical framework for the research, as well as the use of health state utility data from literature to adjust the decision analysis instead of obtaining the data from study participants in Aim 2. This choice was made to avoid increased burden on those participants
- Clarifying that Aims 1 and 2 are separate studies by dividing the background, methods, and results sections to keep these studies separate
Conflict of Interest Disclosures
Study Registration Information
*Patricia A. Parker, PhD was the original principal investigator for this project.
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