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Journal of Clinical Oncology, Vol 25, No 19 (July 1), 2007: pp. 2644-2645 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2007.11.3175
Survival Benefits Associated With Provision of Psychotherapeutic Support to Patients With Gastrointestinal Cancer: Lots of Bang for a Few Bucks?University of Kentucky College of Medicine, Lexington, KY In this issue of the Journal of Clinical Oncology, Küchler et al1 report 10-year survival data for participants in a randomized, controlled trial of psychotherapeutic support for patients with gastrointestinal cancers. Relative to patients who received routine standard of care, they found better 10-year survival rates for patients who received a psychotherapeutic support intervention during their hospitalization for surgery for a gastrointestinal cancer. Specifically, 21.3% of patients (29 of 136) in the intervention arm were alive 10 years postdiagnosis compared with 9.6% of patients (13 of 135) in the control arm. Results of this 10-year follow-up mirror those of a 2-year follow-up of this same intervention study reported previously.2 This report represents the latest in a series of reports of randomized, clinical trials published over nearly the past two decades that have examined survival benefits associated with psychosocial interventions delivered to cancer patients. Beginning with the landmark report by Spiegel et al3 on significantly better survival among women with metastatic breast cancer participating in supportive-expressive group therapy, this area of research has been controversial. Several reviews of this literature have appeared in recent years 4-7 and the conclusions drawn from both individual studies and the reviews themselves have varied. For every individual study reporting a positive impact of psychosocial intervention on survival,3 there appear to be one or more published studies reporting no effect of psychosocial intervention on survival.8-10 Furthermore, reviews have typically been highly critical of the methodologic quality of the research in this area. This is not surprising. Scientifically rigorous implementation of any psychosocial intervention outcome study is extraordinarily difficult and requires enormous resources and diligent oversight and monitoring. When such outcome studies are conducted in the medically and biologically complex context of cancer diagnosis and treatment, the result is not surprising: methodologic weaknesses lead to inconsistent results and ultimately controversy regarding the impact of psychosocial interventions on biologic outcomes. The present study by Küchler et al is certainly no exception to this general state of affairs. Those skeptical of claims that psychosocial interventions can prolong survival after cancer diagnosis will certainly find much to criticize here. Clearly, this is not a report of a neat and clean, highly controlled laboratory study. For example, the intervention itself was not well-standardized leading to uncertainty regarding the precise nature of the intervention. In part, of course, this reflects the clinical need to tailor the intervention to suit the needs and circumstances of individual study participants. Study participants were heterogeneous with regard to diagnosis and treatment and a fairly large proportion (16%; 44 of 271) of them were allowed to crossover to the alternate study arm after random assignment. The intervention was implemented by a limited number of therapists (ie, two) leading to concern regarding therapist-specific effects. Finally, and perhaps most critically, the cytotoxic therapy received by study participants was only crudely characterized. For purpose of the Cox proportional hazards analyses, cytotoxic treatment received by a study participant in addition to surgery was treated as a single dichotomous variable (yes v no). The type, dosage, and duration of any additional therapy (eg, radiation, chemotherapy) were not quantified at all. If one seeks to ascertain the independent impact of psychosocial intervention on survival, the failure to adequately account for the impact of treatment on survival represents a critical shortcoming and weakens the conclusions that can be drawn regarding the independent impact of psychosocial intervention. However, having said that, the results of the study by Küchler et al cannot and should not be completely ignored. After all is said and done and the appropriate methodologic mea culpas have been muttered, 10-year survival in the treatment arm was more than twice that of the control arm (21% v 9%). In contrast to other potential study end points such as depression, anxiety, or quality of life, the use of survival as an end point eliminates, or certainly greatly minimizes, potential sources of measurement error. Whether or not a study participant is alive at some point in time after study entry can often be quantified with a high degree of precision. While some misclassification of survival status is always possible, this study's use of three different information sources to ascertain survival status creates a high level of confidence in the accuracy of their primary study end point. Furthermore, while it is always possible that the findings of Küchler et al could be attributable to chance, the logic of inferential statistics suggests this is very unlikely. Thus, even while acknowledging the methodologic limitations of the Küchler et al study, it is difficult to escape the conclusion that provision of psychotherapeutic support in this clinical setting was generally associated with some survival benefit. Furthermore, this study is noteworthy for its testing of an individualized, hospital-based intervention very soon after a diagnosis of gastrointestinal cancer. Thus, this study stands in contrast to the majority of studies in this field that have tested the survival benefits of group- and outpatient-based interventions with female breast cancer patients3,9,10—the majority of the time without a great deal of success. Given a need to identify specific interventions that work for specific populations, the data reported here merit attention because of the novelty of the intervention and the study population. However, while the results of the Küchler et al study are certainly intriguing, they are also disappointing. To echo the lyrics from a Buffalo Springfield song entitled, For What It's Worth, "there's something happening here, what it is ain't exactly clear." While participants in the intervention arm showed evidence of better 10-year survival rates than participants in the control arm, we have absolutely no understanding of why this might have occurred. The authors suggest several mechanisms that might account for the survival benefits associated with receipt of psychotherapeutic support. These include improved coping, greater awareness of health behaviors, enhanced social support, and more efficient immune function due to fear reduction. However, their discussion of these mechanisms is exceedingly brief and the reader gets the vague impression the investigators do not really care why their intervention might have influenced survival. Therein lies a primary weakness of not only this study, but this entire line of research—a general failure to devote sufficient attention to identifying why psychosocial intervention might influence biologic outcomes. Reports that psychosocial interventions can influence biologic outcomes in cancer patients are often met with skepticism, if not scorn. As noted earlier, this is often due to the presence of notable methodologic weaknesses in each individual study. However, this skepticism is also likely due to the failure of investigators to provide evidence regarding the mechanisms by which psychosocial interventions influence biologic outcomes. Scientific advancement of this line of research, as well as greater clinical acceptance of the possibility that psychosocial interventions can significantly impact biologic outcomes in cancer patient (at least under some conditions), will be dependent on both strengthening the methodologic sophistication of trials as well as designing trials to address questions regarding specific mechanisms of action. Every trial examining the impact of a psychosocial intervention on biologic outcomes should be driven by a well-developed conceptual model. This conceptual model should, at minimum, specify linkages among the specific components of the intervention itself (ie, the active ingredients), specific psychosocial or physiological processes affected by the intervention (ie, mechanisms of action), the biologic and clinical characteristics of the particular cancer patient population wherein the intervention is to be tested, and both intermediate and final end points. The trial should then be designed to incorporate appropriate measurement of each of the critical components of this conceptual model. It has been nearly 20 years after the landmark report by Spiegel et al on the positive impact of a psychosocial intervention on survival for women with metastatic breast cancer.3 While subsequent research has generally failed to replicate these initial positive findings, by no means should this area of research be abandoned. Rather, different types of conceptually grounded interventions need to be tested in diverse groups of cancer patients. Furthermore, the field needs to mature, the scientific bar needs to be raised. Demonstration that a particular type of psychosocial intervention positively impacts survival in a particular group of cancer patients needs to be accompanied by data that sheds light on why this is the case. Only then can investigators begin to hope to silence the skeptics and achieve wider acceptance of this important line of research—and nobody should doubt the potential clinical importance of this line of research. To appreciate the potential clinical significance discussed in this article, one need only note the survival benefits in the intervention arm were achieved with expenditure of an average of 222 minutes of therapist-patient contact per patient matched by a similar amount of time interacting with the patient's physician. Thus, the intervention impacted survival with a total investment of only 7 to 8 hours of therapist time per patient—a day's work. Assuming total annual costs of supporting a therapist on staff were in the range of $150,000 to $200,000 (US dollars), this roughly translates into an investment of $600 to $800 per patient. For less than $1,000 then, one might expect to double the likelihood that a patient would be alive 10 years postdiagnosis. I know of no medical intervention that could be implemented with gastrointestinal cancer patients that would be expected to deliver this big a bang for so few bucks. For this reason alone, the study by Küchler et al is significant and strongly merits further consideration and follow-up. AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. REFERENCES
1. Küchler T, Bestmann B, Rappat S, et al: Impact of psychotherapeutic support for patients with gastrointestinal cancer undergoing surgery: 10-year survival results of a randomized trial. J Clin Oncol 25:2702-2708, 2007 2. Küchler T, Henne Bruns D, Rappat S, et al: Impact of psychotherapeutic support on gastrointestinal patients undergoing surgery. Hepatogastroenterology 46:322-335, 1999[Medline] 3. 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] 4. Chow E, Tsao MN, Harth T: Does psychosocial intervention improve survival in cancer? A meta-analysis. Palliat Med 18:25-31, 2004 5. Edelman S, Craig A, Kidman AD: Can psychotherapy increase the survival time of cancer patients? J Psychosom Res 49:149-156, 2000[Medline] 6. Ross L, Boesen EH, Dalton SO, et al: Mind and cancer: Does psychosocial intervention improve survival and psychological well-being? Eur J Cancer 38:1447-1457, 2002[CrossRef][Medline] 7. Spiegel D: Effects of psychotherapy on cancer survival. Nat Rev Cancer 2:383-389, 2002[CrossRef][Medline] 8. Cunningham AJ, Edmonds CV, Jenkins GP, et al: A randomized controlled trial of the effects of group psychological therapy on women with metastatic breast cancer. Psychooncology 7:508-517, 1998[CrossRef][Medline] 9. 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 10. Kissane D, Love A, Hatton A, et al: Effect of cognitive-existential group therapy on survival in early-stage breast cancer. J Clin Oncol 22:4255-4260, 2004
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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