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© 1999 American Society for Clinical Oncology Mastectomy or Lumpectomy? Helping Women Make Informed ChoicesFrom the Supportive Cancer Care Research Unit and Departments of Medicine, Clinical Epidemiology and Biostatistics, and Surgery, McMaster University, Hamilton; Hamilton Regional Cancer Centre, Hamilton; Henderson Division, Hamilton Health Sciences Corporation, Hamilton; Ottawa Civic Hospital, Ottawa; Brantford General Hospital, Brantford; Department of Surgery, University of Toronto, Toronto; St. Catharines General Hospital, St. Catharines; and Guelph General Hospital, Guelph, Ontario, Canada. Address reprint requests to Timothy J. Whelan, BM, BCh, MSc, c/o Hamilton Regional Cancer Centre, 699 Concession St, Hamilton, ON L8V 5C2 Canada; email tim_whelan{at}hrcc.on.ca
PURPOSE: To develop an instrument to help clinicians inform their patients about surgical treatment options for the treatment of breast cancer and to evaluate the impact of the instrument on the clinical encounter. METHODS: We developed an instrument, called the Decision Board, to present information regarding the benefits and risks of breast-conserving therapy (lumpectomy plus radiation therapy) and mastectomy to women with early-stage breast cancer to enable them to express a preference for the type of surgery. Seven surgeons from different communities in Ontario administered the instrument to women with newly diagnosed clinical stage I or II breast cancer over an 18-month period. Patients and surgeons were interviewed regarding acceptability of the instrument. The rates of breast-conserving surgery performed by surgeons before and after the introduction of the instrument were compared. RESULTS: The Decision Board was administered to 175 patients; 98% reported that the Decision Board was easy to understand, and 81% indicated that it helped them make a decision. The average score on a true/false test of comprehension was 11.8 of 14 (84%) (range, 6 to 14). Surgeons found the Decision Board to be helpful in presenting information to patients in 91% of consultations. The rate of breast-conserving surgery decreased when the Decision Board was introduced (88% v 73%, P = .001) CONCLUSION: The Decision Board is a simple method to improve communication and facilitate shared decision making. It was well accepted by patients and surgeons and easily applied in the community.
RANDOMIZED TRIALS comparing mastectomy to breast-conserving therapy (lumpectomy plus radiation therapy) have demonstrated equivalent survival.1-7 Thus the choice of treatment must be made on the basis of issues relating to quality of life, eg, the loss of the breast and potential effects on body image and sexuality versus an additional 5 to 7 weeks of radiation therapy with its associated side effects. Recent studies of clinical practice have shown wide geographic variation in the type of breast cancer surgery performed in North America and Europe.8-11 Geographic variation in treatment practice may result from disease, institutional, practitioner, and patient-specific factors.12 Studies suggest that the variability observed in the type of breast cancer surgery performed is unlikely to be fully explained by disease factors (such as extent of cancer) or institutional factors (such as access to radiation therapy).8-16 Other research had identified problems with communication of information between physicians and cancer patients.13,14 There remains concern that patients may not be fully informed regarding their treatment alternatives and/or may be overly influenced by the preference of their physician.8,15 In the past, physicians often tended to make decisions for patients with little patient input.16,17 More recently, patients with cancer have indicated a need for more information about their disease and a desire to be involved in decisions about their care.18,19 This has been particularly true for women with breast cancer.20 Shared treatment decision making involves providing information to patients on the benefits and risks associated with different treatment alternatives and incorporating patients' values in the treatment decision.21 The Decision Board was developed to facilitate communication of information to cancer patients and enhance their ability to express a treatment preference.22 The Decision Board, a visual aid administered by the health professional, presents written and graphical information from randomized trials to patients regarding their treatment options.23-25 Previous studies have suggested that the instrument increases patient comprehension and empowers patients in the decision-making process.23 A Decision Board that presents information regarding the benefits and risks of mastectomy and breast-conserving therapy to women with early breast cancer in a standardized and unbiased fashion may improve information transfer and enable patients to express a preference for the type of surgery performed. Most breast cancer surgery is performed by general surgeons in community settings. Previous Decision Boards have been developed for patients and their oncologists in tertiary cancer centers. In this article, we describe the development of a Decision Board for patients and their surgeons in the community regarding the choice of surgical treatment for breast cancer. The results in terms of the acceptability and feasibility of the Board are reported. We also examine the rate of breast-conserving surgery performed before and after the use of the Decision Board in the community.
Instrument Development To develop the surgical Decision Board, we used methodology previously described.22-25 A systematic review of the literature was performed for studies comparing mastectomy and lumpectomy plus radiation for outcomes regarding survival, recurrence, and quality of life. We identified six randomized trials, one meta-analysis, 19 studies comparing the quality of life of the two different treatment approaches, and one systematic review.1-7,26-45 Individual interviews were held with two community surgeons and five women with breast cancer to identify important informational needs for decision making about breast cancer surgery. After the literature review and interviews, two focus groups were assembled to identify the main characteristics of an effective decision aid. The first group included five patients and the second group included five general surgeons. Before the meetings, each participant was provided with background information regarding the two treatment options, the side effects associated with each treatment, and the effects of each treatment on recurrence, survival, and quality of life. The groups discussed and proposed information to be included in the decision aid. The main recommendations from the patient group were to include information regarding breast reconstruction, to provide a visual representation of the breast after mastectomy and breast-conserving therapy, and to provide a separate discussion of the potential effects of treatment on day-to-day living, body image, and sexuality. The surgeons recommended providing more detailed information about the side effects of surgery and radiation therapy. Based on these recommendations, scenarios were developed regarding the following: background information (about the disease and the purpose of the decision instrument); the two treatment options, mastectomy and lumpectomy plus radiation; the acute and long-term side effects associated with each treatment; and the effects of each treatment on the patient's breast, long-term survival, and quality of life. A prototype visual aid was constructed to present the information in an efficient and standardized manner. The instrument was then presented to the focus groups for review of content and clarity. Refinements were made based on feedback. The Decision Board was then piloted with two community surgeons and three patients at the decision point. Based on their responses, minor revisions were made. The Decision Board is composed of laminated foam core and measures 25 inches wide by 20 inches high (Fig 1). It is large enough to permit the patient to read the display, but not so large or heavy to be cumbersome to store or carry. The board has four subtitles: Treatment Choice, Side Effects, Results of Treatment Choice for the Breast and Results of Treatment Choice for Survival. Below each heading are two informational panels (one for mastectomy and one for lumpectomy plus radiation) resulting in eight separate panels. The instrument is administered by the surgeon. Initially, each panel is covered by a sliding door. The panels are opened to reveal information in a sequential fashion. Each panel is read together by the patient and the surgeon. The patient is encouraged to ask questions during the presentation and afterward. At the end of the presentation, the patient is faced with an overall visual representation of her two options and the possible outcomes associated with each choice. In addition to the board, there are two separate informational cards, one is to be read before the presentation and discusses background information about breast cancer and the purpose of the board, and one is to be read after the presentation and asks the patient to reflect on how the treatment will affect her as an individual (see Appendix). An additional card providing further details regarding breast reconstruction is also made available. Upon completion of the Decision Board presentation, the patient is given a take-home version to review and discuss with others if she so desires.
The Decision Board was piloted with 30 healthy female volunteers to determine its validity and reliability. The instrument was administered on two occasions by a skilled interviewer. On the first occasion, the instrument was administered using standard information and the woman was asked to state her preference for mastectomy or lumpectomy plus radiation. Validity was then assessed by changing the information provided and determining whether preferences changed in a predictable manner. For example, if a woman chose lumpectomy plus radiation, information was then conveyed in which the difference in survival for lumpectomy plus radiation as compared with mastectomy was gradually decreased. It was predicted that if patients were told that there was a substantial decrease (20%) in survival associated with lumpectomy plus radiation, the majority of patients would choose mastectomy. For women who chose mastectomy, a similar but opposite approach was used. At the second visit, 3 to 4 weeks later, the instrument was readministered with standard information only and the patient was asked to state a preference. The mean age of volunteers was 57.3 years; 17 (57%) were married and 16 (53%) had some postsecondary education. Thirty (100%) considered the Decision Board to be easy to understand and 24 (80%) found it helpful in making a decision. Twenty-nine (97%) volunteers recommended that it should be used for breast cancer patients. At first administration, 19 (63%) chose lumpectomy plus radiation and 11 (37%) chose mastectomy. In women who chose lumpectomy plus radiation, 17 (89%) switched preference when survival was decreased. For those women who chose mastectomy, nine (82%) switched preference when survival was reduced. Women's responses were stable over time. On readministration of the instrument 3 to 4 weeks later, 28 (93%) had the same preference (kappa statistic = 0.86).
Evaluation All potentially eligible patients were identified by participating surgeons. Patients were recruited over an 18-month period from June 1996 to November 1997. Patients who met exclusion criteria were logged but were not approached to participate in the study. Consenting eligible patients were administered the Decision Board. A decision regarding treatment was made either at that visit or a few days later and surgery was scheduled. Patients were then interviewed by telephone by a skilled research assistant within 1 to 2 weeks. During the interview, which took 30 to 40 minutes to administer, patients were questioned regarding background demographic variables, preferences for involvement in decision making, general acceptability of the decision aid, comprehension of basic information relevant to decision making, satisfaction with information received and the decision-making process, other aspects regarding decision making (eg, Did they perceive a choice? Did the surgeon make a recommendation?), and their final treatment decision. Patient preference for decision making was assessed using a 6-point Likert scale modeled on an instrument developed by Degner et al46: 1 = "I prefer to make the final decision about which treatment I receive;" 2 = "I prefer to make the final selection of my treatment after seriously considering my doctor's opinion;" 3 = "I prefer that my doctor and I share responsibility for deciding which treatment is best for me;" 4 = "I prefer that my doctor makes the final decision about which treatment will be used, but seriously considers my opinion;" 5 = "I prefer to leave all decisions regarding my treatment to my doctor;" and 6 = "I am unsure." General acceptability of the decision aid was assessed by asking patients questions about how well they understood the Decision Board, its usefulness in helping them make a decision, its usefulness in helping them to think of questions to ask, and whether they would recommend it for others. Patient comprehension was assessed by correct responses to 14 statements that covered various content areas (description of options, side effects, and outcomes) using a "true, false, or unsure" type of format. Patient satisfaction with information received and decision-making was assessed using a 5-point Likert scale from 1 (Strongly Agree) to 5 (Strongly Disagree). Surgeons were asked to complete a self-administered questionnaire after administration of the instrument for each patient. The questionnaire included items regarding the process of decision making, and acceptability and satisfaction with the decision aid. Administration of the instrument was also timed on a sample of patients (n = 20). In an effort to determine if the introduction of the Decision Board influenced clinical practice in terms of the type of surgery performed, we reviewed the charts of all newly diagnosed stage I or II patients seen by each surgeon for an 18-month period before the introduction of the Decision Board. Similar exclusion criteria as used for patients in the Decision Board cohort were applied. Age, marital status, clinical stage, and type of surgery performed were abstracted for all eligible patients. Patients seen for the two time periods before and after the introduction of the Decision Board were compared.
Statistical Analysis In an effort to determine if any factors (eg, physician or patient characteristics) predicted a patient's choice for surgery, a multivariate logistic regression analysis was performed. Variables examined in the model included patient's age, marital status, level of education, dependent children, socioeconomic status, distance from the nearest radiation therapy facility, clinical stage, surgeon seen, gender of the surgeon, surgeon's recommendation, and recommendation from the spouse or first-degree relative.
Patients seen before and after the introduction of the Decision Board were compared with respect to demographic characteristics and disease stage using contingency
Patient and Surgeon Characteristics A total of 244 patients were initially screened for study eligibility; 65 were excluded by participating surgeons. Thirty-three patients were excluded because of medical contraindications (eg, technical factors [large tumor-to-breast ratio], multicentric carcinoma, diffusely abnormal mammogram, or comorbidity), 19 patients were excluded because of administrative issues (eg, non–English speaking, seen in hospital, or approached for another clinical trial), and 13 patients were excluded for other reasons (eg, a previous contralateral mastectomy or lumpectomy). Of 179 patients identified as eligible, 175 agreed to presentation of the Decision Board. Four patients refused to use the Decision Board because they had already made a decision about treatment and did not want to discuss treatment options. The mean age of consenting patients was 56.2 years (range, 33 to 80 years). Seventy percent had high school education or greater, 46% were employed outside the home, and 20% had dependent children. Other demographic and disease characteristics are listed in Table 1.
The mean age of the surgeons was 42.2 years (range, 36 to 50 years); three were female and two had an academic affiliation. The mean number of patients who were administered the Decision Board by each surgeon was 25 (range, nine to 74).
Decision-Making Process The average score on the true/false test of comprehension was 11.8 of 14 (84%) (range, 6 to 14). The proportion of correct responses for each statement was greater than 70% for all statements except for one relating to skin telangectasia after breast irradiation postlumpectomy (Table 2). Ninety-seven percent of patients reported satisfaction with the information received, and 95% reported satisfaction with the decision-making process.
The Decision Board took an average of 21 minutes to administer. Surgeons reported being comfortable with the administration of the instrument (mean score of 89 on a linear analog scale from 1 to 100). Surgeons found the Decision Board helpful in presenting information to patients in 91% of consultations, and reported being satisfied with the decision-making process in 97% of consultations. Physician satisfaction did not correlate with the number of times the board was used (P = 0.23) In most instances (57%), the patient's decision was made during the consultation. In a minority of cases, the decision was made a couple of days after the consultation (32%) or before the consultation itself (11%). All but three patients perceived that they had been offered a clear choice regarding treatment options. Patients reported that surgeons made a recommendation in 39% of encounters. In most of these (78%), the patient had requested a recommendation. Forty-seven percent of patients sought advice from other individuals, including spouse (n = 20), other first-degree relatives (n = 27), friends (n = 21), or family doctor (n = 19). In all, 73% of patients chose lumpectomy and radiation, 26% chose mastectomy. (Two patients elected not to have any form of surgical treatment and chose alternative therapies instead.) On multivariate analysis, the only factor that predicted for a patient's choice was the surgeon's recommendation for the type of surgery (P = .0001). Two hundred thirty-nine patients underwent surgery in the practice during the 18 months before the introduction of the Decision Board. Forty-five were excluded: 26 because of medical contraindications, nine because of administrative issues, and 10 for other reasons. The remaining 194 patients were compared with 175 patients who were administered the Decision Board. Both groups were comparable with respect to marital status, age, and stage of disease (Table 1). Breast-conserving surgery was performed more commonly before the introduction of the Decision Board (170 of 194 [88%] v 127 of 175 [73%], P = .001).
For women with early breast cancer, the decision regarding the optimal form of surgical treatment is not straightforward. We developed a Decision Board to help surgeons present information regarding the benefits and risks of the two treatment options to women diagnosed with early breast cancer to enable them to express a preference for treatment. Previous Decision Boards regarding the choice of adjuvant therapies were developed in a tertiary cancer center.22-25 Instruments were targeted primarily to younger women 4 to 6 weeks after their initial diagnosis and were administered by academic oncologists or primary care nurses. The Decision Board for breast cancer surgery was a departure from previous work. It was introduced to women of all age groups shortly after their diagnosis and administered by general surgeons in the community. The surgical Decision Board seemed to be well accepted by patients and surgeons alike. The majority of patients indicated a desire to be involved in decision making in a manner that is consistent with that of previous studies of women with breast cancer,20 and almost all patients who were approached agreed to administration of the instrument. Comprehension of information was very good. The majority of patients who used the Decision Board were very satisfied with the information exchanged and the decision-making process. Almost all patients felt they were offered a clear choice. Surgeons also reported similar high satisfaction and comfort with administration of the instrument. The board took on average only 20 minutes to administer and did not seem to unduly lengthen the consultation. These results are consistent with our previous experience with such instruments in tertiary cancer centers. In the regression analysis, the only variable that independently predicted choice was the surgeon's recommendation for either lumpectomy or mastectomy. In most of these cases, the patients had requested a recommendation. These results suggest that patients' preferences cannot be predicted a priori and support the use of the Decision Board to incorporate patients' preferences in difficult treatment decisions. The impact of the Decision Board on treatment practice was evaluated using a before/after design. The rate of breast-conserving surgery decreased (with a corresponding increase in the use of mastectomy) after the introduction of the Decision Board. Surgeons participating in the study performed breast-conserving surgery relatively commonly before the introduction of the Decision Board. When women were offered a choice of treatment with the use of the Decision Board, breast-conserving surgery was performed less often. Many of these women supported their decision by indicating that they wanted to avoid radiation therapy and were less concerned about body image. The observed results were unexpected. It is unclear whether these results are due to the use of the Decision Board or the nature of our study design (before/after). It might be expected that in certain circumstances the Decision Board would affect a patient's choice, such as when patients are not clearly informed of their different treatment options, when detailed information regarding the different treatment options and associated outcomes are not provided, or when patients are not actively involved in the decision-making process. One or all of these reasons may have explained the results observed in our study. Before introduction of the Decision Board, surgeons may not have clearly offered the different treatment options of mastectomy or lumpectomy. Additionally, details regarding the need for radiation treatment after lumpectomy and the risk of recurrence of cancer in the breast may not have been routinely presented. Finally, before the use of the Decision Board, patients' preferences may not have been routinely elicited. The ideal design to evaluate the impact of the Decision Board is a randomized controlled trial. This type of design was beyond the scope of the present study. Furthermore, a randomized controlled trial is not without its own methodologic problems. In a randomized trial, surgeons using the Decision Board may tend to adopt this approach (or a similar one) in standard practice, leading to the problem of contamination. A larger study in which surgeons are randomized to use the instrument or not may avoid this problem. The design we chose also circumvented this concern, but was at potential risk of bias due to confounding changes in patterns of practice over time. To avoid this, we evaluated all eligible patients over two consecutive relatively short periods of time. An important attribute of the Decision Board is that it can be easily modified to incorporate local variations in practice or changes to treatment approaches over time. Recently published randomized trials suggest a survival benefit for locoregional radiation therapy after mastectomy in women with node-positive breast cancer treated with systemic therapy.47,48 Based on the results of these studies, it is anticipated that locoregional radiation therapy will be offered more frequently to women at high risk of locoregional recurrence. This adds to the complexity of the treatment decision-making process. However, usually there is a sequence of treatment decisions for early-stage breast cancer. The decision for locoregional radiation is most often made by the patient and her oncologist after surgery when important pathologic information is available. In addition, many women will have node-negative breast cancer, and the use of locoregional radiation therapy postmastectomy is unlikely to be an option. A brief discussion of the use of locoregional radiation therapy after mastectomy treatment could be included in the surgical decision aid, but for the majority of women, this decision is likely to be best made after surgery. Various types of decision aids have been developed to facilitate communication of information to patients and elicit their treatment preferences. Aside from decisional analysis,49 which is an indirect method for eliciting patients' preferences for treatment, direct methods that involve the use of visual aids, audio tapes,50 and computer technology51 have been advocated because they make few assumptions and are more easily administered. In trying to develop a decision aid for breast cancer surgery, we identified several criteria that we felt were important: (1) The instrument should encourage direct two-way communication in addition to information transfer. This was an important consideration. Patients have indicated that the choice of breast cancer surgery is an important decision, and relationship building seems to be an important component of shared decision making.21 (2) The instrument should not take too long to administer, and it should be inexpensive and easy to use. (3) The instrument should have been used previously with oncology patients. The Decision Board met these criteria. The surgical Decision Board was shown to facilitate shared decision making. It was well accepted by patients and surgeons and was easily applied in the community. These results support its wider use in clinical practice.
Introduction: Breast cancer may be treated in a variety of ways, including surgery, radiation therapy, chemotherapy, and hormonal therapy. The first step in the treatment of breast cancer is to remove the cancer by surgery. Today we will discuss the two choices for surgical treatment. This is not a decision that I, as your doctor, can make alone. We feel it is important for you to understand a little bit about breast cancer so you can take part in deciding what is best for you. Two types of surgery are possible: one is removal of the breast, called a mastectomy; the second is removal of the lump, called lumpectomy. Since the early 1980s, the results of medical studies have shown that the two treatments are the same for survival. In other words, one treatment is not better than the other for improving your chances of surviving cancer. The two treatments do differ, however. Mastectomy results in the loss of your breast, and usually no radiation therapy is required. Lumpectomy, on the other hand, involves removal of the part of the breast that contains the cancer, and in addition, radiation therapy is offered. Both of these treatments also include an axillary node dissection. Some nodes or glands under the arm are removed at the time of surgery. This is done to see if the cancer has spread to these nodes. If cancer spreads to these nodes, there is a higher chance that the cancer may spread to other parts of the body. This is important information for you and your doctor to help to decide if other treatments, such as hormonal therapy or chemotherapy, are necessary. Other Issues: We have discussed your choices for surgery, what that entails, the side effects, and possible outcomes. I have a copy of the information presented on the Decision Board for you to take home. In choosing between the two options, please read carefully and make sure that you understand what is available. Remember, the chance for survival is the same for each choice. So in deciding between the two options, think about the issues that will affect your day-to-day life. Keep in mind that every woman is different and that you must choose the option that is best for you. You may want to consider some of the following:
• How will the results of your treatment choice affect the way you feel about your self, your body, and your sexuality? • How will the results of your treatment choice affect your relationships with others? • Will the treatment you choose be inconvenient for you? Consider the length of the treatment and the need to travel to the cancer center. Some women find it helpful to speak with other women who have been through a similar experience. If you would like to speak with another woman with breast cancer, this can be arranged.
Supported by the Canadian Breast Cancer Research Initiative, and a Health System Linked Research Grant (no. 04171) from the Ontario Ministry of Health. We thank Angela Frisina, Marguerite Neimanis, and Ann Fucic for their assistance with the development and design of the Decision Board and data collection for this study.
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Copyright © 1999 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
2 tests. The rates of breast-conserving surgery for the two time periods were compared with the 
