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Journal of Clinical Oncology, Vol 23, No 8 (March 10), 2005: pp. 1627-1630 © 2005 American Society of Clinical Oncology. DOI: 10.1200/JCO.2005.10.072
Physician/Patient Decision Aids for Adjuvant Therapy
From the Juravinski Cancer Centre, Hamilton, Ontario, Canada; and the Mayo Clinic, Rochester, MN Address reprint requests to Timothy J. Whelan, BM, BCh, MSc, Juravinski Cancer Centre, 699 Concession St, Room 3-62, Hamilton, Ontario, L8V 5C2 Canada; e-mail: tim.whelan{at}hrcc.on.ca.
Many women with breast cancer are requesting more information about their disease, and studies suggest that they have an increasing desire to be involved in decisions about their care.1 To participate in decision making regarding adjuvant therapy, a woman needs accurate information about her options, associated adverse effects, and her risk of recurrence with and without treatment. A basic prerequisite of informed decision making is that a woman needs to understand this information as best as possible. Clinical studies have identified problems with both determining the risk of recurrence for individual patients2,3 and communicating this information in the clinical consultation.4,5 Pursuant to this, a number of physician/patient decision aids have been developed to address these problems. Decision aids are tools designed to help people make specific and deliberative choices among different options by providing information on the options and outcomes relative to a person's health6; these aids can take many forms. They may include combinations of written and visual information such as decision boards or flip charts, audio or video tapes, and interactive computer driven multimedia programs.7 Decision aids, generally, are meant to supplement, not replace, the traditional process of patient counseling by the physician. A decision aid should include a clear description of treatment options, including associated benefits and risks. The information provided should be evidence based and tailored to individual patients. The effectiveness of the instrument, in terms of improving patient knowledge and facilitating decision making should be demonstrated in clinical trials and the instrument should be easy to use and accessible.7 Currently, there are a number of instruments that have been developed as decision aids for adjuvant therapy in breast cancer. The Decision Board (Supportive Cancer Care Research Unit, Hamilton, Ontario, Canada) is a visual aid that a doctor or nurse can use to present information to the patient on her adjuvant therapy options, associated risks of recurrence, adverse effects, and potential impact on the patient's quality of life.8 The instrument is 24 inches wide x 18 inches high and contains written and graphic information (Fig 1). The information is presented to the patient in successive panels in a sequential fashion. At the end of the presentation, the patient is faced with an overall visual representation of her options and the possible outcomes associated with each option. The patient is given a take-home version to review and discuss with others, if she desires.
The Decision Board provides information on risk of recurrence with and without adjuvant therapy. Risks of recurrence without adjuvant therapy are determined from randomized clinical trials based on well-known prognostic factors such as the number of involved nodes and tumor size and grade. The risks of recurrence with adjuvant therapy are provided based on proportional risk reductions determined from the Early Breast Cancer Trialist Collaborative Group (EBCTCG) overview.9,10 The instrument is easy to use and can be modified as new information becomes available. Randomized trials have demonstrated that the Decision Board improves patients' knowledge about their disease and risk of recurrence, and increases their satisfaction and confidence with decision making.11,12 These studies have demonstrated that anxiety is not increased with the use of the aid. Currently, the instrument is not widely available. A computer-based version of the Decision Board is being evaluated in a randomized trial. Another instrument, called the Shared Decision Making Program (Foundation for Informed Medical Decision Making, Boston, MA), uses an interactive computer video program to provide information on adjuvant therapy options.13 The instrument may be reviewed by the patient alone, or with a health educator. Instruments such as this have been shown, in randomized trials for non–cancer-related disease, to improve patient knowledge and satisfaction with decision making.14,15 Two other widely known prognostic tools, Adjuvant! (Adjuvant! Inc, San Antonio, TX)16 and Numeracy (Mayo Foundation for Medical Education and Research, Rochester, MN)17 are computer-based programs designed to assist in adjuvant therapy decision making. Both programs determine a patient's baseline risk of recurrence and/or death at 10 years without adjuvant therapy, based on prognostic factors such as the number of involved axillary nodes and primary tumor size. Both tools provide an estimate of the absolute benefit associated with different popular adjuvant therapies such as CMF and anthracycline- or taxane-based chemotherapy, and hormonal therapies such as tamoxifen and the third generation aromatase inhibitors (Fig 2). These benefits are based on proportional risk reductions determined from EBCTCG overview.9,10 Printouts of prognostic information provided by these tools can be produced to aid in treatment discussions with patients. These instruments are freely available on the Internet for physician use (www.adjuvantonline.com and www.mayoclinic.com/calcs).
Despite providing similar estimates of baseline risk and absolute benefits, the instruments do differ.18 The Adjuvant! program is based on data from the Surveillance, Epidemiology, and End Results database. Estimates of risk of recurrence for this program have recently been validated in a prospective population-based study.19 Numeracy, in contrast, determines baseline prognostic estimates based on a panel of experts. The Adjuvant! program, in addition, provides the ability to include prognostic information on tumor grade and has the capacity to add additional prognostic factors such as ploidy and HER-2/neu status. Adjuvant! provides details on risk of noncancer death, which may be relevant for older patients who are at risk. In addition to providing estimates of risk of recurrence and death, Adjuvant! also provides information on toxicity data for different systemic regimens. One of the advantages of the Numeracy program is its simplicity and ease of use. Other similar prognostic tools, such as the Nottingham Prognostic Index, have also been developed and modified to be used as decision aids regarding adjuvant therapy.20,21 However, to date, their applicability in the physician/patient consultation has not been extensively studied. Thus, an increasing number of instruments are available to facilitate doctor/patient decision making regarding adjuvant therapy in breast cancer. A number of these instruments are easy to use and some are accessible over the Internet. While studies have shown some of these instruments to improve patient knowledge and facilitate shared decision making, a number of basic questions still remain unresolved. How well do patients understand the information provided by current Internet tools? What level of detail do women desire, for example, do they require precise numerical risks of recurrence?22 Do they want more details on side effects and their incidence? What is the best format to facilitate understanding about risk of recurrence? How will new prognostic and predictive factors such as multiplex gene expression or detection of micrometastases, discussed elsewhere in this issue, be incorporated in current tools? Is the information provided by these tools enough or can other approaches such as individual counseling facilitate a woman's ability to understand complex information and participate in treatment decision making?23 These are all important questions that will need to be addressed as clinicians endeavor to involve patients more in decision making regarding adjuvant therapy for breast cancer.
The authors indicated no potential conflicts of interest.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
1. Ravdin PM, Siminoff IA, Harvey JA: Survey of breast cancer patients concerning their knowledge and expectations of adjuvant therapy. J Clin Oncol 16:515-521, 1998[Abstract] 2. Sawka CA, O'Connor AM, Llewellyn-Thomas HA, et al: Appropriateness of adjuvant systemic therapy for axillary node-negative breast cancer: A physician opinion survey. J Clin Oncol 13:1459-1469, 1995[Abstract] 3. Loprinzi CL, Ravdin PM, DeLaurentiis M, et al: Do American oncologists know how to use prognostic variables for patients with newly diagnosed primary breast cancer? J Clin Oncol 12:1422-1426, 1994[Abstract] 4. Siminoff LA, Fetting JH, Abeloff MD: Doctor-patient communication about breast cancer adjuvant therapy. J Clin Oncol 7:1192-1200, 1989[Abstract]
5. Leighl N, Gattellari M, Butow P, et al: Discissing adjuvant cancer therapy. J Clin Oncol 19:1768-1778, 2001 6. O'Connor AM, Stacey D, Entwistle V, et al: Decision aids for patients facing health treatment or screening decisions (Cochrane Review), in: The Cochrane Library, Issue 1, 2004. Chichester, UK, John Wiley & Sons Ltd, 2004 7. Whelan TJ, O'Brien MA, Villasis-Keever M, et al: Impact of cancer-related decision aids. Evidence report/technology assessment number 46. AHRQ Publication No. 02-E004. Rockville, MD, Agency for Healthcare Research and Quality, 2002 8. Levine MN, Gafni A, Markham B, et al: A bedside decision instrument to elicit a patient's preference concerning adjuvant chemotherapy for breast cancer. Ann Intern Med 117:53-58, 1992 9. Anonymous: Polychemotherapy for early breast cancer: An overview of the randomized trials. Early Breast Cancer Trialists' Collaborative Group. Lancet 352:930-942, 1998[CrossRef][Medline] 10. Anonymous: Tamoxifen for early breast cancer: An overview of randomized trials. Early Breast Cancer Trialists' Collaborative Group. Lancet 351:1451-1467, 1998[CrossRef][Medline]
11. Whelan T, Sawka C, Levine M, et al: Helping patients make informed choices: A randomized trial of a decision aid for adjuvant chemotherapy in lymph node-negative breast cancer. J Natl Cancer Inst 95:581-587, 2003
12. Whelan T, Levine M, Willan A, et al: Effect of a decision aid on knowledge and treatment decision making for breast cancer surgery: A randomized trial. JAMA 292:435-441, 2004
13. Chapman G, Elstein A, Hughes KK: Effects of patient education on decisions about breast cancer treatments. Med Decis Making 15:231-239, 1995
14. Murray E, Davis H, Tai SS, et al: Randomised controlled trial of an interactive multimedia decision aid on benign prostatic hypertrophy in primary care. BMJ 323:493-496, 2001 15. Morgan MW, Deber RB, Llewellyn-Thomas HA, et al: Randomized, controlled trial of an interactive videodisc decision aid for patients with ischemic heart disease. J Gen Intern Med 15:685-693, 2000[CrossRef][Medline]
16. Ravdin PM, Siminoff LA, Davis G, et al: Computer program to assist in making decisions about adjuvant therapy for women with early breast cancer. J Clin Oncol 19:980-991, 2001
17. Loprinzi C, Thome SD: Understanding the utility of adjuvant systemic therapy for primary breast cancer. J Clin Oncol 19:972-979, 2001 18. Loprinzi C, Ravdin PM: Decision-making for patients with respectable breast cancer: Individualized decisions for and by patients and their physicians. Journal of the National Comprehensive Cancer Network 1:189-96, 2003 19. Olivotto I: An independent population-based validation of the adjuvant decision-aid for stage I-II breast cancer. J Clin Oncol 22:14S, 2004 (abstr 522; suppl) 20. Blamey R: The design and clinical use of the Nottingham Prognostic Index in breast cancer. Breast 5:154-167, 1996 21. Feldman M, Standford R, Catcheside A, et al: The use of a prognostic table to aid decision making on adjuvant therapy for women with early breast cancer. Eur J Surg Oncol 28:615-619, 2002[CrossRef][Medline]
22. Chao C, Studts JL, Abell T, et al: Adjuvant chemotherapy for breast cancer: How presentation of recurrence risk influences decision-making. J Clin Oncol 21:4299-4305, 2003
23. Sepucha KR, Belkora JK, Tripathy D, et al: Building bridges between physicians and patients: Results of a pilot study examining new tools for collaborative decision making in breast cancer. J Clin Oncol 18:1230-1238, 2000 Submitted October 28, 2004; accepted December 10, 2004.
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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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