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Journal of Clinical Oncology, Vol 24, No 22 (August 1), 2006: pp. 3711-3712 © 2006 American Society of Clinical Oncology. DOI: 10.1200/JCO.2006.06.9369
In ReplyCancer Outcomes Research Program, Cancer Care Nova Scotia and Dalhousie University, Halifax, Nova Scotia, Canada
Ontario Clinical Oncology Group, Juravinski Regional Cancer Centre, and McMaster University, Hamilton, Ontario, Canada
Ontario Clinical Oncology Group, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada In Reply: We appreciate the opportunity to reply to the letter from Drs Ellen Warner and Judith Weinroth. In this letter, they describe a process of preselection of patients that they implemented in their own clinics and, hence, raise questions about the generalizability of the trial evaluating family physician versus specialist follow-up of patients with early-stage breast cancer.1 That only a small fraction of cancer patients are enrolled onto clinical trials is a well-recognized and multifactorial problem. Among the problems are physician-related factors such as the preselection of patients by their treating physician.2-4 It is both necessary and ethical for patients to be approached about clinical trials by their treating physician, raising the potential for an unavoidable preselection bias in all clinical trials. The challenge is, within this necessary constraint, to conduct and report the results of the trial in a transparent way so that its external validity (generalizability) to the larger target population can be assessed.5 To achieve this, we carefully documented the prerandomization experience of this trial, which is summarized in the Consolidated Standards for Reporting Trials6 Figure 1.
The enrollment of patients onto the trial varied among the cancer centers that participated. For example, in the center of Drs Warner and Weinroth (which is in the single largest metropolitan area in Canada), the smallest proportion of patients was enrolled (33 of 968 patients; 3.4%). The proportion of oncologists agreeing to have eligible patients approached was 64%, whereas, in the other centers, the proportion ranged from 77% to 88%. Similarly, at their center, 42% of patients approached agreed to participate compared with 52% to 68% of patients at the other centers. As described by Drs Warner and Weinroth, the most frequent reason cited by oncologists for not agreeing to have a patient approached was that the patient was high risk. One can appreciate that their experience of this trial is reflective of the experience at their center, which was not typical of the other participating centers. Which centers are more reflective of the target patient population can be debated. However, the point is that the participating patients are generalizable to the population of women diagnosed with breast cancer,5 the majority of whom are node negative (see Table 1: Baseline Characteristics of Study Participants1). Drs Warner and Weinroth also question whether the trial truly reflects long-term follow-up. As we state in the article,1 the median follow-up time of patients was 4.5 years after diagnosis. The primary outcome of the trial was serious clinical events at the time of diagnosis of recurrence. Although breast cancer recurrence can occur for many years beyond diagnosis, the majority of events do take place within the first 5 years. The clinical events studied are rare, and the likelihood of detecting more events by prolonging the trial was small and, therefore, not justifiable. Similarly, it would be difficult to justify continuance of the trial for the secondary outcome of health-related quality of life, which is unlikely to be affected by longer follow-up. We hope we have addressed the issues raised by Drs Warner and Weinroth. We also hope that, in the spirit of shared decision making,7 Drs Warner and Weinroth will share the results of this trial with their patients so that the patients themselves can make an informed choice about future follow-up. Dr Rosenzweig suggests that oncology nurse practitioners based in oncology practices are well suited for the purpose of caring for the unique concerns8 of breast cancer survivors and calls for a nurse-led model of care to be evaluated. We agree that interventions to address these concerns are important, but they were beyond the scope of our study, which focused on long-term routine follow-up care as currently practiced. In fact, nurse-led models of care have been widely evaluated, and the results have been equivocal because of limitations in the study design and outcomes.9-13 Even when the interventions have proven benefits,14 the evidence does not support the continued long-term follow-up of the majority of breast cancer patients in oncology clinics, whether the practitioner is a physician or a nurse. Such long-term follow-up leads to further fragmentation of care and increased health care and patient costs without proven benefits for patients. Authors' Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest.
REFERENCES
1. Grunfeld E, Levine MN, Julian JA, et al: Randomized trial of long-term follow-up of early-stage breast cancer: A comparison of family physician versus specialist care. J Clin Oncol 24:848-855, 2006 2. Mansour EG: Barriers to clinical trials: Part III. Knowledge and attitudes of health care providers. Cancer 74:2672-2675, 1994[CrossRef][Medline] 3. Grunfeld E, Zitzelsberger L, Coristine M, et al: Barriers and facilitators to enrollment in cancer clinical trials. Cancer 95:1577-1583, 2002[CrossRef][Medline] 4. Wright JR, Crooks D, Ellis PM, et al: Factors that influence the recruitment of patients to phase III studies in oncology. Cancer 95:1584-1591, 2002[CrossRef][Medline] 5. Wright JR, Bouma S, Dayes I, et al: The importance of reporting patient recruitment details in phase III trials. J Clin Oncol 24:843-845, 2006 6. Altman DG, Schulz K, Moher D, et al: The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Ann Intern Med 134:663-694, 2001 7. Charles C, Gafni A, Whelan T: Self-reported use of shared decision-making among breast cancer specialists and perceived barriers and facilitators to implementing this approach. Health Expect 7:338-348, 2004[CrossRef][Medline] 8. Grunfeld E, Dhesy-Thind S, Levine M: Clinical practice guidelines for the care and treatment of breast cancer: Follow-up after treatment for breast cancer (summary of the 2005 update). CMAJ 172:1319-1320, 2005 9. James ND, Guerrero D, Brada M: Who should follow up cancer patients? Nurse specialist based outpatient care and the introduction of a phone clinic system. Clin Oncol (R Coll Radiol) 6:283-287, 1994[Medline] 10. Earnshaw JJ, Stephenson Y: First two years of a follow-up breast clinic led by a nurse practitioner. J R Soc Med 90:258-259, 1997[Abstract] 11. Gulliford T, Opomu M, Wilson E, et al: Popularity of less frequent follow up for breast cancer in randomized study: Initial findings from the hotline study. BMJ 314:171-177, 1997 12. Brown L, Payne S, Royle G: Patient initiated follow up of breast cancer. Psychooncology 11:346-355, 2002[CrossRef][Medline] 13. Ritz LJ, Nissen MJ, Swenson K, et al: Effects of advanced nursing care on quality of life and cost outcomes of women diagnosed with breast cancer. Oncol Nurs Forum 27:923-932, 2000[Medline] 14. Ganz PA, Greendale GA, Petersen L, et al: Managing menopausal symptoms in breast cancer survivors: Results of a randomized controlled trial. J Natl Cancer Inst 92:1054-1064, 2000
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Copyright © 2006 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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