Development of a patient decision aid for choice of surgical treatment for breast cancer

Abstract

Purpose A patient decision aid for the surgical treatment of early stage breast cancer was developed and evaluated. The rationale for its development was the knowledge that breast conserving therapy (lumpectomy followed by breast radiation) and mastectomy produce equivalent outcomes, and the current general agreement that the decision for the type of surgery should rest with the patient.

Methods A decision aid was developed and evaluated in sequential pilot studies of 18 and 10 women with newly diagnosed breast cancer who were facing a decision for breast conserving therapy or mastectomy. Both qualitative (general reaction, self‐reported anxiety, clarity, satisfaction) and quantitative (knowledge and decisional conflict) measures were assessed.

Results The decision aid consists of an audiotape and workbook and takes 36 min to complete. Based on qualitative comments and satisfaction ratings, 17 of 18 women reported a positive reaction to the decision aid, and all 18 reported that it helped clarify information given by the surgeon. Women did not report an increase in anxiety and 17 of 18 women were either satisfied or very satisfied with the decision aid.

Conclusion This pilot study supports the hypothesis that this decision aid may be a helpful adjunct in the decision for surgical management of early stage breast cancer. We are currently conducting a randomized trial of the decision aid versus a simple educational pamphlet to evaluate its efficacy as measured by knowledge, decisional conflict, anxiety and post‐decisional regret.

Introduction

Numerous randomized trials have demonstrated the equivalence of mastectomy and breast conserving therapy (lumpectomy followed by breast radiation) with respect to local recurrence rates and overall survival for early stage breast cancer. ¹ , 2, 3, 4, 5, ^–6 Some relative contraindications to breast conserving therapy exist including large tumour relative to the size of the breast, true multifocal disease and inability to undergo breast radiation. ⁷ For most women with stage I or II breast cancer, mastectomy and breast conserving therapy are both appropriate management options. It is generally agreed that the decision for one or the other should be based on a woman's personal preference after she has considered the advantages and disadvantages of each procedure in discussion with the surgeon. ⁸ This concept is key to the Cancer Care Ontario Clinical Practice Guideline (CCOCPG) for surgical management of breast cancer. ⁸ Significant geographical variation in the use of breast conserving therapy has been identified ⁹ , 10, 11, 12, ^–13 and evidence suggests that surgeons' opinions and preferences may be the most important factors in this observed variation. ^{11 , 14 , 15} These findings are inconsistent with the view that, whenever possible, the decision for local surgical management should be shared by the patient and her surgeon.

Recently, the paternalistic model of medical decision making, in which doctors make decisions on behalf of their patients, has been challenged and consumers and health care professionals alike have stressed the need to better inform patients of their treatment options in order to facilitate shared decision making. ¹⁶ , 17, 18, 19, 20, 21, 22, 23, 24, 25, ^–26 In a shared decision making model, patients are encouraged to express their preferences and values and to participate in decisions about their health care. ²⁷ The extent to which individual patients wish to participate in these decisions varies considerably, however, as some patients wish to make the choice without physician input, while patients at the other end of the spectrum defer to the physician. ²⁷ The benefits of shared decision making, apart from its consistency with the concept of patient autonomy, have been demonstrated in a variety of clinical scenarios. Patients who are offered a choice in therapy report greater satisfaction with the decision making process and less anxiety than those who perceive they were not given a choice in management. ²⁸ , 29, 30, 31, 32, ^–33 Whether this is due, at least in part, to the superior communications skill of practitioners who offer a choice, or the actual offer of choice, remains controversial. ³³

Decision aids provide information in order to facilitate shared decision making. They differ from traditional educational material in their emphasis on alternatives, detailed descriptions of risks and benefits, use of explicit probabilities in presenting risks and benefits, and, where possible, tailoring of information to specific patients. ³⁴ Some decision aids also provide explicit values clarification exercises where the patient considers the personal importance of the described risks and benefits in arriving at a decision. ³⁴ , 35, ^–36

Women facing the choice of surgical management of breast cancer may be particularly well suited to use of a decision aid as previous studies have documented that women with breast cancer tend to have high information needs and strong desires to participate in treatment decisions. ^{37 , 38}

Previous decision aids for breast cancer have focused on decisions which are made well after the time of diagnosis, such as the use of adjuvant chemotherapy for node‐negative disease, and the use of radiation after lumpectomy. ^{39 , 40} These decision aids have been administered and evaluated largely in tertiary level cancer centres. In contrast, the breast cancer surgery decision is made soon after time of diagnosis, which can be a highly emotional period, often in the offices of community‐based surgeons.

This report describes a program of research to develop, evaluate and disseminate a decision aid for this purpose. We have previously described the results of a needs assessment which involved focus groups of women with a previous diagnosis of breast cancer. ⁴¹ The decision aid development and pilot evaluation is described here. An important secondary objective of this pilot study was to assess the feasibility of administering the decision aid and conducting research soon after breast cancer diagnosis. Using the knowledge gained in the pilot study phase, we are conducting an evaluation of the breast cancer surgery decision through a randomized trial in the community setting.

Methods

Development of the decision aid

A steering committee, which comprised an academic surgeon, a community surgeon, a radiation oncologist, a medical oncologist, a breast cancer survivor, and two researchers in decision sciences and health services research, oversaw all aspects of development and evaluation of the decision aid.

The information content and format for the decision aid were developed through an iterative process that included, in addition to the steering committee's input, a systematic literature review, a needs assessment based on focus groups of women with previous diagnosis of breast cancer, input from key informants, and comments from women who were at the point of making a decision about breast surgery (See Fig. 1).

Figure 1.

Flow diagram of steps in the development and pilot evaluation of the decision aid.

Literature review

The content and recommendations are based on the CCOCPG for surgical management of breast cancer. This guideline was developed using a structured process which involved a systematic review of all relevant literature. ⁸ We supplemented this information with a systematic review of adverse events from radiation treatment.

Input from key informants

The two surgeons and the radiation oncologist on the steering committee provided a transcript of what they normally discussed in a `typical' patient consultation regarding choice of surgery, and from these, key content items were identified.

Needs assessment

Concurrently we conducted a needs assessment by holding focus groups of women with previous diagnoses of breast cancer to ascertain the information they received at diagnosis and the information they wished they had received in retrospect. We also obtained their opinions on the optimal format and content of a decision aid for surgical management of breast cancer. Detailed results from the needs assessment have been described ⁴¹ and we briefly present pertinent findings here. Twenty‐two women participated in one of five focus groups. The age range was 25–60 years at the time of diagnosis. Thirteen women had undergone lumpectomy plus radiation while nine had undergone mastectomy. Half of the women studied worked outside the home. The groups comprised members of a breast cancer activist group, women affiliated with, or who have participated in, breast cancer support groups, women without any such group affiliation, women from a mixed rural suburban setting, and a group of women recruited by the Ontario Chapter of the Canadian Cancer Society.

Several themes emerged from the focus groups. Although women were satisfied with the information provided by their surgeons, their emotional state at the time of diagnosis influenced the retention of the information provided. Women consistently indicated that they would have liked to have seen more information available at the time of their surgical consultation for review later at home. They stated that the need for further information manifested itself at different times following diagnosis and therefore, they wanted additional sources of information which they could consult with later. Women wanted a decision aid to: augment the surgical consultation, but not to replace it; contain photographs and realistic probabilities of adverse reactions; and have a format which could be reviewed in privacy and repeated as often as they wished.

Review of and revisions to draft decision aid

A variety of formats were considered and audiotape and an accompanying workbook was chosen. The decision aid is described in more detail later (see Results). A draft decision aid was reviewed and critiqued by the steering committee, by nine of the women who had previously participated in the needs assessment described above and by two radiation oncologists not associated with the study. After further revisions the first pilot study commenced. The revised decision aid was also reviewed by four surgeons not associated with the steering committee and by two focus groups of oncology nurses (seven nurses in total).

Pilot studies

Pilot study I

The first pilot study of the revised draft decision aid involved 18 women who had just been diagnosed with breast cancer and who were making a decision about surgical management. The study was conducted in the offices of the surgeons on the steering committee, one academic and one community‐based centre.

Consecutive women with newly diagnosed stage I or II breast cancer were eligible provided the surgeon believed that both mastectomy and breast conserving therapy were appropriate. Women had to have good comprehension of English and provide informed consent. After a discussion with the surgeon about the diagnosis and treatment options, the patient reviewed the decision aid in the presence of the research nurse who answered any questions. All 18 patients gave their impressions and reactions to this decision aid. After a preliminary phase with six patients (three from the academic centre and three from the community centre) during which logistic issues were clarified, the next 12 patients (nine from the academic centre and three from the community centre) were asked to complete a questionnaire of knowledge (Breast Cancer Information Test; BCIT). ⁴² The last eight of these 12 women also completed a decisional conflict questionnaire (Decisional Conflict Scale; DCS). ⁴³

Final revisions to decision aid

The comments of the four external surgeons and the seven oncology nurses and the patients who participated in the Pilot Study I were considered and appropriate revisions were made. This last product will be referred to as the Final Decision Aid.

Pilot study II

A pilot study of the Final Decision Aid was then conducted. This involved 10 additional patients (five from the academic centre and five from the community centre). Eligibility criteria were identical to those for Pilot Study I, however, in Pilot Study II, women reviewed the decision aid after their surgical consultation and in the absence of the study nurse. They completed the BCIT and the DCS.

Ethics approval

Approval for this study was obtained from the Research Ethics Board at Sunnybrook Health Science Centre, Toronto, Canada.

Results

Decision aid description

The decision aid contains specific information regarding the options of lumpectomy followed by breast radiation and mastectomy with respect to: the surgical procedure; expected need for radiation following surgery; description of radiation; possible short‐ and long‐term side‐effects of radiation; appearance after mastectomy (including with a prosthesis and after reconstructive surgery); and possible differences in future follow‐up and the need for repeat biopsy of suspicious areas. Wherever possible, published results of frequencies of complication rates and recurrence risks were used. The steering committee reached consensus on those topics for which no published information was available, such as description of surgeries and radiation treatment.

The format of the decision aid was adapted from O'Connor et al. ³⁴ An audiotape workbook format was chosen because of its suitability for use in community surgeons' offices and women's homes, the ease of updating information and incorporating values clarification exercises, and the preference of the focus groups. Portability of the decision aid and low relative costs compared with other formats such as computer‐based interactive media would permit each woman to have her own personal copy.

The decision aid workbook content is geared to grade eight reading level but is comprehensible to those with lower reading levels because of the illustrations and accompanying audiotape. The audiotape, recorded in a comforting female voice, is 26 minutes long and supplements the workbook. The booklet uses colour photographs of lumpectomy, acute and long‐term radiation reactions, and mastectomy with and without reconstruction to illustrate cosmetic results, and describes the likelihood of events in graphical form using 100 figures to provide quantitative information. For example, Fig. 2 shows the results achieved with mastectomy. The accompanying audiotape text is:

Figure 2.

Appearance after mastectomy. Photographs are used to demonstrate the appearance following mastectomy with a breast prosthesis following reconstructive surgery.

the second option is mastectomy… shown on page 5. In this procedure the entire breast is removed – so the chest will be flat. To give your body the appearance of a natural breast – a breast `prosthesis' can be used. This is a soft object shaped like your breast which fits into your bra. Or… you could have additional “reconstructive” surgery. This rebuilds the removed breast – to give a fairly natural breast appearance.

Figure 3 shows longterm skin changes after radiation. The accompanying audiotape text states:

Figure 3.

Possible permanent skin changes after radiation. The likelihood of each outcome is shown graphically and the cosmetic results are illustrated with photographs.

Once the early side‐effects of radiation disappear, you may experience some permanent effects later on. The box on page 17 contains 100 symbols representing 100 women receiving radiation. The shaded areas show the number expected to experience permanent radiation effects. The lines point to pictures which show the possible outcomes. About 50 of 100 women will have minimal or no permanent skin changes. Another 40 of 100 women will have moderate tanning and thickening. Fewer than 10 out of 100 women will develop a deeply tanned breast which is hard or “woody” to the touch. Swelling and scarring are not common.

Wherever management is not dependent on the choice of locoregional therapy, such as the decision for axillary dissection and the use of adjuvant systemic therapy, this point is made explicitly.

Finally the booklet contains a values clarification exercise ( Fig. 4). This is a three step process which uses the analogy of a `balance scale' where lumpectomy and mastectomy are on opposite sides. First, the woman is asked to review the advantages and disadvantages of both lumpectomy with radiation and mastectomy as provided, and to list additional ones. Second, she considers the value of each of the advantages and disadvantages by shading each box according to its personal importance (no shading = not important to me; complete shading = extremely important to me). In the third step, the user examines her worksheet to identify whether she is `leaning' toward lumpectomy followed by radiation or toward mastectomy. Before the woman completes her own worksheet, several examples are provided. These hypothetical cases illustrate the range of women's‐values and how they influence their decisions. They reinforce the notion that there is no right or wrong choice and that the decision is based on a woman's personal values.

Figure 4.

Values clarification exercise. Step I: list advantages and disadvantages of each procedure. Step 2: indicate personal importance of each point by shading. Step 3: identify 'leaning'.

Pilot study results

Results are presented separately for the 18 patients reviewing the revised Draft Decision Aid (Pilot I) and the 10 who reviewed the Final Decision Aid (Pilot II).

As shown in Table 1, the participants for both Pilots I and II were varied in their age, marital status, education, level and employment status. The median time to review the decision aid was 36 min (range 28–55 min). The 18 participants in Pilot Study I gave qualitative impressions of the Revised Draft Decision Aid. Sixteen of 18 women found the photographs useful in decision making while two found them `scary but real'. Ten of 18 found no areas which were unclear. Three respondents thought the discussion of adjuvant systemic therapy was somewhat unclear and there were single requests for more details on each of the following: long‐term radiation effects, breast reconstruction, `staging tests', breast recurrence rate, and the timing of the surgical decision. These responses were used to revise the Draft Decision Aid. Seventeen of 18 women had a positive reaction to the decision aid. Although only five out of 18 felt that the decision aid raised new questions about what the surgeon first explained, all women felt that the decision aid helped clarify information given by the surgeon. Anxiety as assessed by self report was largely unaffected (13/18) or relieved (4/18) after use of the decision aid. Seventeen of 18 women reported that they were either `satisfied' or `very satisfied' with the decision aid. Table 2 gives representative examples of participants' qualitative comments.

Table 1.

Patient demographics

Table 2.

Representative examples of participants′ qualitative comments

The results of the knowledge scale, the BCIT‐Revised for 12 patients in pilot I and 10 patients in pilot II ( Table 3) demonstrated that the questions which dealt with topics discussed explicitly in both the Draft and Final Decision Aids (bold items Table 3) were generally answered correctly. In contrast, those topics not covered in either version were less likely to be answered correctly (plain items Table 3). The high number of incorrect responses to questions 5 and 10 (italicized items in Table 3) in Pilot I were used to revise the wording of the knowledge questionnaire slightly for clarity prior to use in Pilot II. (Question 5: changed from `fatigue is an infrequent…' to `fatigue is not a frequent…', question 10: changed from `breast sparing surgery' to `lumpectomy'.)

Table 3.

Breast Cancer Information Test – Revised (BCIT‐revised).

Results of the DCS are shown in Table 4. The DCS consists of 16 questions with an overall score and subscales which address uncertainty; modifiable factors contributing to uncertainty such as feeling uninformed, clarity of values, and inadequate social support; and perceived effective decision making. ⁴³ The DCS has been demonstrated to be valid and responsive to change as it detects clinically important differences. The subscale scores suggest that although respondents feel informed, have clear values, report good social support and perceived effective decision making, they remain somewhat uncertain about their decisions. In the DCS, the overall score and subscale scores can range between 1 (low decisional conflict) and 5 (high decisional conflict). Previous work has suggested that those who accept interventions after being informed have mean scores of less than 2, while those who delay decisions have mean scores above 2.5. The mean overall scores in this small sample, 1.81 ± 0.31 (SD) for Pilot I (n = 8) and 2.2 ± 0.37 (SD) for Pilot II (n = 10), are consistent with respondents who make decisions after being informed.

Table 4.

Decisional conflict scale (DCS) responses

Discussion

Decision aids are intended to provide information and to clarify personal values in order to facilitate shared decision making ³⁴ , 35, ^–36 . Previous work has demonstrated that women who are offered a choice of surgery for early stage breast cancer are more satisfied with the decision and exhibit less anxiety and depression in subsequent months. ³¹ , 32, ^–33 The communication style of the surgeon who offers a choice may well be an important factor in these results. ³³ We developed and evaluated a decision aid for surgical management of early stage breast cancer in response to requests by consumers and health care professionals ^{26 , 41} and the knowledge that women with breast cancer have high information needs and frequently desire a participatory role in decision making. ^{37 , 38} A needs assessment using focus groups of women with a previous diagnosis of breast cancer, followed by an iterative process involving a multidisciplinary Steering Committee, further focus groups of women and clinicians and a sequence of pilot studies was essential in helping to clarify the necessary content and appropriate format for the decision aid.

The pilot study demonstrated that a self‐administered audiotape workbook decision aid can be used to augment the surgical consultation at the time of breast cancer diagnosis. Women liked the audiotape workbook format, the use of photographs and the values clarification exercise. Women felt the content was clear and reinforced information already provided by the surgeon. The responses to the knowledge items reflected the content of the decision aid. Self‐reported anxiety levels were not increased and women were satisfied with their review of the decision aid.

We administered the DCS primarily to assess the feasibility of using it in a future randomized trial and any interpretation of these early results is therefore tentative. The results of this small sample do suggest, however, that women may feel knowledgeable about the choices, the risks and benefits, and the personal importance of each of the risks and benefits. Even after using the decision aid, however, the DCS scores suggested that some uncertainty remains about the decision. We hypothesize that this is because the decision is a difficult one and involves the balancing of advantages and disadvantages. Although decision aids may reduce uncertainty due to modifiable factors, such as poor knowledge, unclear values and inadequate support, they will not reduce uncertainty inherent in making a difficult, often emotionally charged, decision. Second, the decision aid provides only a part of the decision support. Women, after reviewing the decision aid, need to resolve any remaining uncertainty in a follow‐up discussion with the surgeon, family and friends.

There have been several criticisms raised of the shared decision making model, but this study addresses many of them. It has been argued that not all women wish to participate in decision making. ²⁷ The pilot study confirmed this, but did find, as previously demonstrated, that despite variable preferences for participation in decision making, all women were grateful for the information provided. ⁴⁴ , 45, 46, 47, 48, 49, 50, 51, ^–52 A second criticism has been that anxiety may be increased through the use of shared decision making. ^{27 , 53} Self reported anxiety was unaffected or reduced in this study, based on qualitative responses and decisional conflict questionnaire scores. A third criticism has been the cost and time required to provide all relevant information. ²⁷ Since the instrument is self‐administered it is specifically intended not to add to the consultation time and it is cheaper than interactive media. A final argument against the shared decision making model is the fear that patients will demand too much and therefore utilize scarce resources inappropriately. ²⁷ This appears not to be a valid concern for the development of a breast cancer surgery decision aid as breast conserving therapy and mastectomy are widely regarded as equivalent options which should be made available to all eligible women. ⁸ Thus, these results support a shared decision making approach using a decision aid, particularly where surgical choices with equivalent treatment outcomes exist.

Decision aids may have some limitations, including the complexity of distribution, the need to tailor information according to local practice, and the need to update them as new information becomes available. There is also concern that decision aids may lead to complacency and may abrogate the physician's responsibility to communicate with patients effectively.

A secondary objective of this study was to assess whether conducting communications research with decision aids is feasible at this initial stage of breast cancer management. Previous decision aids in breast cancer have addressed decisions which are made well after the time of diagnosis, and published pilot studies have been conducted in tertiary level cancer centres. ^{39 , 40} The audiotape workbook was specifically developed for use in community surgeons offices and was intended to be used at the time of the diagnosis, as a supplement to the surgical consultation. Feasibility issues such as access to eligible women and acceptability of such a study have not been previously addressed. The study demonstrated that women are willing to enroll in a decision aid study when approached by community‐based as well as academic surgeons. In our pilot studies, the eight women recruited from a community‐based surgeon reviewed the decision aid after their surgical consultation and were able to complete questionnaires of decisional conflict, knowledge and anxiety for measurement of relevant outcomes.

The data from this small pilot study supports the hypothesis that this decision aid may be a very helpful adjunct in the decision for surgical management for early stage breast cancer. Demonstration of efficacy is required before the decision aid is advocated on a wide spread basis. To this end we are currently conducting a randomized trial of the decision aid vs. an educational pamphlet which contains similar information, but without photographs, explicit probabilities or a values clarification exercise. In this trial, community‐based surgeons in Ontario are allocated randomly to distribute the decision aid or pamphlet to eligible consenting women. The major outcome measures for this study are knowledge and decisional conflict, while secondary outcomes are anxiety and post decisional regret. The trial will also determine if certain subsets of women, for example, those with strong preferences for participation in decision making, may derive greater benefit from an audiotape workbook format. Undoubtedly the decision aid will continue to evolve as our understanding of both the early management of breast cancer and our knowledge of decision aids progresses.

Acknowledgements

This study was supported by the Institute for Clinical Evaluative Sciences in Ontario. Dr Goel is supported in part by a National Health Scholar Award from Health Canada. We thank Pamela Slaughter and S. Patricia Pinfold for conducting the focus groups, Laura Benben for the graphic design of the draft decision aid, and Correna Stogios for secretarial assistance.