|
Advertisement |
|
|
||
 |
|
|||||
|
|||||
|
 |
||||||
|
||||||
|
||||||
|
Originally published as JCO Early Release 10.1200/JCO.2004.06.926 on September 27 2004 © 2004 American Society of Clinical Oncology.
Support Groups in Breast Cancer: When a Negative Result Is PositiveSamuel Lunenfeld Research Institute at Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada One could say that psycho-oncology has come of age in the last decade. This area of oncology, which emerged about a quarter of a century ago, is now established worldwide as a key component of multidisciplinary cancer care in comprehensive cancer centers. Much of the early research activity in this area focused on learning more about the psychosocial impact of cancer on patients, family, and friends. Later research involved intervention studies examining the impact of psychosocial interventions on the well-being and outcome of cancer patients. This research is rapidly providing the foundation for an evidence-based approach to psycho-oncology practice. In 1989, Spiegel et al1 from Stanford University (Stanford, CA) reported an unexpected survival benefit in women with metastatic breast cancer who were randomly assigned to receive weekly supportive-expressive group therapy or standard medical therapy in a trial that was originally designed to examine the impact of such therapy on psychological status and pain control. Overall survival had doubled in the intervention arm, an effect that remained highly statistically significant after controlling for potential confounding factors. However, because the survival analysis was not a primary goal of the study, and because of baseline imbalances in potentially important prognostic factors between the two study arms, replication was recommended. Several researchers, including Spiegel himself, undertook the challenge. Three subsequent studies have been conducted involving women with metastatic breast cancer,2-6 one of which examined the supportive-expressive group therapy used by Spiegel et al.2 The first of these studies, by Edelman et al,3,4 examined the benefits of a cognitive behavioral support group intervention involving eight weekly sessions followed by three monthly sessions. Although there was evidence of short-term improvements in mood (depression, total mood disturbance) and enhanced self-esteem,3 there was no evidence of a survival benefit.4 Edmonds et al 5 and Cunningham et al5,6 evaluated an intervention that included group sessions incorporating discussion, supportive strategies, and cognitive behavioral therapy. No survival benefits were observed, and the authors reported "little" psychometric benefit. It is important to note that the control arm in this study did receive an important degree of intervention: a home cognitive behavioral therapy program that included a coping skills workbook, relaxation tapes, and supportive phone calls on five occasions over 1 year. Finally, our group2 reported the results of a multicenter, randomized trial of supportive-expressive group therapy. The therapy in this trial was similar to that used in the original Spiegel et al study1; in fact, Dr Spiegel was involved in training all of the therapists and in monitoring compliance throughout the study. The group intervention enhanced mood (total mood disturbance, anger, anxiety, depression, and confusion) and reduced perceived pain severity; exploratory analyses revealed that these benefits were limited to women experiencing distress at study entry. No survival benefits were seen despite a greater than 90% power to identify the survival effects that had been reported by Spiegel et al. Spiegel's own group has reported psychological outcomes of their replication study7 in which women randomly assigned to the intervention arm reported significantly reduced traumatic stress symptoms and, if the final assessment performed during the last year of life was excluded, a significant improvement in mood. To date, survival outcomes have not been reported. Thus, none of the replication studies of Dr Spiegel's work in metastatic breast cancer has reported a survival benefit for a variety of group therapies. In this issue of the Journal of Clinical Oncology, Kissane et al8 report survival outcomes from a randomized trial of a 20-week cognitive-existential group therapy for women receiving adjuvant chemotherapy, which included women at an earlier stage of breast cancer than those investigated in the earlier studies reviewed in this editorial. Kissane et al report a result that is clearly negative with respect to survival; there was no evidence of a survival benefit in women randomly assigned to group therapy plus relaxation, compared with women who received a relaxation intervention only. Detailed multivariate modeling that included key tumor-associated, patient-related, and treatment variables identified no significant survival effects, with a hazard ratio of 1.37 (95% CI, 0.73 to 2.32; P = .37) for death in the multivariate model in women randomized to the group intervention. An earlier report9 arising from this study had identified psychosocial benefits for women randomly assigned to the group intervention; these women reported reduced anxiety, greater satisfaction with therapy, and a trend toward improved family functioning. Thus, the findings of Kissane et al are consistent with the three recent randomized trials in metastatic breast cancer, and they extend the finding that group psychosocial interventions do not prolong the survival of women with early-stage breast cancer. For many, the report from Kissane et al will be viewed as the final nail in the coffin for potential survival benefits of psychological interventions in cancer. Certainly, based on current evidence in breast cancer, there is little reason for optimism. The evidence in other tumor types is equally unconvincing. Three trials involving psychosocial interventions in other malignancies have identified survival benefits while two have not, and none of the positive results have been replicated. Richardson et al10 identified a survival benefit in individuals with hematologic malignancies who received a compliance-enhancing intervention. Kuchler et al11 reported prolonged survival in those receiving a very brief, inpatient, individual psychotherapeutic intervention in a variety of gastrointestinal cancers. Fawzy et al12 reported a survival benefit for a brief, 6-week, group psychoeducational intervention in early-stage melanoma, an effect that was attenuated with longer follow-up.13 Ilnyckyj et al14 and Linn et al15 failed to find survival benefit for those participating in group and individual interventions in mixed-cancer patients and in lung cancer patients, respectively. Although further research may yield different findings, current findings do not support an evidence-based recommendation that psychosocial interventions be offered with the intent to prolong survival. In parallel to this research into survival effects of psychosocial interventions, a considerable body of research has provided evidence of psychological and social benefits for a variety of psychosocial interventions in breast cancer.16 Although not all studies have yielded positive results, some of the benefits listed included improved mood, enhanced coping skills, improved health-related quality of life, reduced uncertainty, and improved self-esteem. The most consistent finding has been improved mood, particularly in the short term. What is remarkable is the breadth of interventions that have been shown to be effective in one situation or another. Structured group therapy, supportive-expressive group therapy, cognitive-behavioral group therapy, a variety of nursing interventions, and relaxation/hypnosis interventions have all been shown to be effective in at least one study. Surprisingly little research has evaluated the impact of individual interventions in breast cancer that are commonly used in the clinical setting. Formal evaluation of such interventions, as well as continuing research elucidating which interventions, and delivered by whom, are most beneficial for which individuals at differing stages of their illness should form the basis for research in this area during the next decade. Such research will provide a body of data that will further promote an evidence-based approach to the practice of psychosocial oncology and ensure that psychosocial oncology is practiced with the same degree of rigor required in other areas of oncology. The National Cancer Policy Board of the Institute of Medicine (Washington, DC) recently addressed the importance of meeting psychosocial needs of women with breast cancer.16 The Board recognized that psychosocial distress in women with breast cancer is frequent, recommended that psychosocial management be an integral part of treatment, and recommended that cancer care providers meet published standards of psychosocial care. It also identified a need for improved professional education and training and for improved research opportunities. The Central European Cooperative Group17 reached similar conclusions at a recent consensus conference on the management of metastatic breast cancer, recommending that psychosocial care be incorporated into multidisciplinary management. That these two organizations came to these conclusions reflects a sea of change in attitudes in recent years. When is a negative result positive? The report by Kissane et al8 provides no evidence of a survival benefit for cognitive-expressive group therapy in women receiving adjuvant chemotherapy for breast cancer. That is a negative result. However, when the study by Kissane et al is placed in context in the much larger field of psycho-oncology research, it serves to focus attention on the gains that have been made in this field during the last quarter of a century, and it reinforces the growing evidence that psychosocial interventions are associated with psychosocial benefits in women with breast cancer. It also helps to focus future research in this field. Thus, the negative result of Kissane et al should have a positive impact on the field of psycho-oncology as a whole—a prime example of a negative result being positive. Author's Disclosures of Potential Conflicts of Interest The author indicated no potential conflicts of interest. REFERENCES 1. Spiegel D, Bloom JR, Kraemer HC, et al: Effect of psychosocial treatment on survival of patients with metastatic breast cancer. Lancet 2:888-891, 1989[CrossRef][Medline]
2. Goodwin PJ, Leszcz M, Ennis M, et al: The effect of group psychosocial support on survival in metastatic breast cancer. N Engl J Med 345:1719-1726, 2001 3. Edelman S, Bell DR, Kidman AD: A group cognitive behaviour therapy programme with metastatic breast cancer patients. Psychooncology 8:306-314, 1999[CrossRef][Medline] 4. Edelman S, Lemon J, Bell DR, et al: Effects of group CBT on the survival time of patients with metastatic breast cancer. Psychooncology 8:474-481, 1999[CrossRef][Medline] 5. Edmonds CV, Lockwood GA, Cunningham AJ: Psychological response to long-term therapy: A randomized trial with metastatic breast cancer patients. Psychooncology 8:74-91, 1999[CrossRef][Medline] 6. Cunningham AJ, Edmonds CV, Jenkins GP, et al: A randomized controlled trial of the effects of group psychological therapy on survival in women with metastatic breast cancer. Psychooncology 7:508-517, 1998[CrossRef][Medline]
7. Classen C, Butler LD, Koopman C, et al: Supportive-expressive group therapy and distress in patients with metastatic breast cancer: A randomized clinical intervention trial. Arch Gen Psychiatry 58:494-501, 2001
8. Kissane DW, Love A, Hatton A, et al: The effect of cognitive-existential group therapy on survival in early stage breast cancer. J Clin Oncol 22:4255-4260, 2004 9. Kissane DW, Bloch S, Smith GC, et al: Cognitive-existential group psychotherapy for women with primary breast cancer: A randomized controlled trial. Psychooncology 12:532-546, 2003[CrossRef][Medline] 10. Richardson JL, Shelton DR, Krailo M, et al: The effects of compliance with treatment on survival among patients with hematologic malignancies. J Clin Oncol 8:356-364, 1990[Abstract] 11. Kuchler T, Henne-Bruns D, Rappat S, et al: Impact of psychotherapeutic support on gastrointestinal cancer patients undergoing surgery: Survival results of a trial. Hepatogastroenterology 46:322-335, 1999[Medline]
12. Fawzy FI, Fawzy NW, Hyun CS, et al: Malignant melanoma: Effects of an early structured psychiatric intervention, coping, and affective state on recurrence and survival 6 years later. Arch Gen Psychiatry 50:681-689, 1993
13. Fawzy FI, Canada AL, Fawzy NW: Malignant melanoma: Effects of a brief, structured psychiatric intervention on survival and recurrence at 10-year follow-up. Arch Gen Psychiatry 60:100-103, 2003 14. Ilnyckyj A, Farber J, Cheang MC, et al: A randomized controlled trial of psychotherapeutic interventions in cancer patients. Ann R Coll Physicians Surg Can 27:93-96, 1994 15. Linn MW, Linn BS, Harris R: Effects of counseling for late stage cancer patients. Cancer 49:1048-1055, 1982[CrossRef][Medline] 16. Hewitt M, Herdman R, Holland J (eds): The effectiveness of psychosocial interventions for women with breast cancer, in Meeting Psychosocial Needs of Women with Breast Cancer, Institute of Medicine and National Research Council of the National Academies. Washington, DC, The National Academies Press, 2004, pp 95-132 17. Beslija S, Bonneterre J, Burstein H, et al: For the Central European Cooperative Group: Consensus on the Medical Treatment of Metastatic Breast Cancer. Breast Cancer Res and Treat, 81:S1–S7, 2003 (suppl 1)
Related Article
This article has been cited by other articles:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||
|
|||||||||||
|
|
Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
|
