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Originally published as JCO Early Release 10.1200/JCO.2005.01.913 on June 6 2005 © 2005 American Society of Clinical Oncology.
How and for Whom? Asking Questions About the Utility of Psychosocial Interventions for Individuals Diagnosed With CancerDivision of Cancer Prevention and Control Research, Jonsson Comprehensive Cancer Center; Departments of Psychology and Psychiatry/Biobehavioral Sciences; Cousins Center for Psychoneuroimmunology; University of California, Los Angeles, Los Angeles, CA A recent review revealed 155 randomized controlled trials of psychological interventions for cancer patients published through 1998,1 and many additional trials have been published since that time. Even a quick examination of the literature on the effects of psychosocial interventions on outcomes related to quality of life, such as psychological adjustment and fatigue in cancer patients, reveals that some randomized controlled trials are impressive in their positive outcomes, some produce mixed results, and some yield null findings. In recent qualitative and quantitative meta-analytic reviews of the relevant body of intervention research, the reviewers draw disparate conclusions, suggesting that the existing evidence demonstrates the utility of psychological interventions,2,3 yields a mixed picture,4-7 or supports no strong recommendations for their effectiveness.1 Just as the intervention studies included within the reviews differ dramatically on a number of dimensions, so do the reviews themselves on such factors as criteria for inclusion, outcomes examined, and approaches to the data. In this issue of the Journal of Clinical Oncology, Chan et al8 provide an example of a randomized controlled trial that yielded negative effects. Rather than continuing to ask the omnibus question of whether psychological interventions are effective for cancer patients and chalking up the trial by Chan et al as one for the "loss" column, posing questions that address the issues of how and for whom specific interventions do or do not carry positive effects might better illuminate directions for this important domain of psychosocial oncology. Asking how an intervention produces its effects involves an exploration of mechanisms or explanations for a trial's findings. Characterizing the pathways through which an intervention produces positive effects can shed light on how the intervention might be refined further, and how seemingly distinct treatments might produce similar effects through common mechanisms. Asking how an intervention might have yielded disappointing findings also can be revealing, both in providing information on how much weight should be accorded to the findings and in helping researchers learn which paths not to pursue in developing interventions in the future. For both positive and negative trials, explanations for results are likely to lie in such factors as the nature of the sample studied, the intervention implemented, and the outcomes examined. For example, Chan et al8 acknowledge the high baseline functioning of the patient sample as a potential explanation for the lack of significant effects. If a sample of cancer patients reports low distress and otherwise high functioning at the outset of a trial, then it is statistically impossible for a significant intervention effect to emerge on those outcomes, at least without a very large sample. A related issue, particularly for trials that target patients during or shortly after medical treatment, is that many individuals tend to recover over time without psychological intervention,9 as also occurred in the trial by Chan et al,8 again working against the likelihood of detecting significant intervention effects over a standard care control. With regard to the nature of the intervention, it is important to note that the intervention by Chan et al8 was multimodal, encompassing such multiple core components as psychoeducation, supportive care, stress management, relaxation, and pain management. Furthermore, the intervention was individually tailored to each participant, with the specific content left to the discretion of the treating psychologist. Although many published psychological interventions also are multimodal and some include individual tailoring, the reader is left with a number of questions regarding the intervention by Chan et al. Among others, these include whether all trial participants received each core treatment component, such as documentation of treatment fidelity through independent ratings of audiotaped sessions for delivery of intervention components, as well as the intended and actually administered dose of the intervention for trial participants. For example, it would be instructive to examine data on number of sessions attended, total contact time, and primary content of the individually tailored intervention, as well as whether these indicators predicted intervention outcomes. The outcomes selected for psychological intervention trials also warrant consideration. Although there is ready theoretical justification for the expectation by Chan et al8 that cancer-specific intrusive thoughts should be responsive to their specific intervention, which components of their intervention, if any, should influence the outcomes of satisfaction with the medical provider or global self-esteem, for example? Reviewers of the psychological intervention literature have suggested that cancer-specific assessments, such as treatment-related fatigue, cancer-specific distress, and sexual functioning, often demonstrate larger intervention effects than do more global psychological and quality-of-life indices.10 It is important to note, however, that Chan et al also found no significant effect on cancer-specific intrusive thoughts. In addition to asking how an intervention carries its effects, posing questions of for whom and under what conditions (such as a point in the cancer trajectory) an intervention is useful can contribute to the development of more effective therapeutic approaches. Although Chan et al8 reports insufficient statistical power to test such moderated effects, one wonders whether the intervention might have been effective relative to the control condition for a subsample that evidenced more marked psychological disturbance or low self-efficacy at baseline compared with more highly functioning participants. Accumulating evidence suggests that psychological interventions may be more effective for individuals who are in greater distress or who have fewer psychosocial resources, such as low social support,11 low optimism,12 or low education,13 and that discrete interventions may be useful for cancer patients with particular characteristics such as high or low cancer-related avoidance.14 Moreover, recent meta-analyses3,7 have produced heterogeneous effect sizes for psychological interventions, also suggesting that the utility of psychological interventions varies as a function of important attributes of the interventions themselves and the targeted participant samples. The next generation of psychological intervention research requires increasingly careful a priori consideration of the nature of the samples, interventions, and outcomes involved, as well as theory-guided examinations of mechanisms for the obtained effects. The observations that many individuals diagnosed with cancer report relatively minimal psychological disruption and that they improve over time without psychological intervention suggest that trials might be targeted most productively toward those who stand to benefit most from interventions.5,15,16 Inclusion criteria can be crafted to select individuals or caregivers who are in distress or who possess few psychosocial resources, with appropriate ethical safeguards implemented for patients randomly assigned to a control group. The approach of offering intervention to those in most need also potentially maximizes the efficient use of scarce resources. Another approach is to identify attributes of the patient population that theoretically are likely to moderate the effects of the intervention, and to build inspection of these moderators into the data analytic plan. Thorough attention to the nature of the intervention and its most theoretically and empirically justifiable outcomes also is essential. Evidence suggests that psychoeducational approaches may be more effective than peer discussion or supportive care,3,17 and that interventions that include components designed to enhance self-regulation and increase self-efficacy with regard to cancer-related issues produce larger effect sizes than do interventions with few or no such components.18 Specification of the most central facets of treatment content and demonstration that the intervention is delivered as intended are crucial elements in psychological intervention research. Efforts to identify the most potent ingredients of multimodal therapeutic approaches also are warranted. Careful specification of outcomes that should be influenced by a particular therapeutic approach will increase the opportunity to detect significant intervention effects, if they indeed exist. Recommendations by such bodies as the National Cancer Policy Board of the Institute of Medicine19 and the Central European Cooperative Group20 that psychosocial care be integrated into oncology care render it imperative that methodologically rigorous investigations set the standard for evidence-based practice. Both in designing psychosocial intervention trials for those diagnosed with cancer and their loved ones, and in evaluating the findings of those trials, considering questions of how and for whom the intervention does or does not work promises to move the field forward in producing maximally effective interventions. Author's Disclosures of Potential Conflicts of Interest The author indicated no potential conflicts of interest. REFERENCES
1. Newell SA, Sanson-Fisher RW, Savolainen NJ: Systematic review of psychological therapies for cancer patients: Overview and recommendations for future research. J Natl Cancer Inst 94: 558-584, 2002 2. Meyer TJ, Mark MM: Effects of psychosocial interventions with adult cancer patients: A meta-analysis of randomized experiments. Health Psychol 14: 101-108, 1995[CrossRef][Medline] 3. Rehse B, Pukrop R: Effects of psychosocial interventions on quality of life in adult cancer patients: Meta analysis of 37 published controlled outcome studies. Patient Educ Couns 50: 179-186, 2003[Medline] 4. Andersen BL: Psychological interventions for cancer patients to enhance quality of life. J Consult Clin Psychol 60: 552-568, 1992[CrossRef][Medline] 5. Andersen BL: Biobehavioral outcomes following psychological interventions for cancer patients. J Consult Clin Psychol 70: 590-610, 2002[CrossRef][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 7. Sheard T, Maguire P: The effect of psychological interventions on anxiety and depression in cancer patients: Results of two meta-analyses. Br J Cancer 80: 1770-1780, 1999[CrossRef][Medline]
8. Chan YM, Lee PWH, Fong DYT, et al: The effect of individual psychological intervention in Chinese women with gynecologic malignancy: A randomized controlled trial. J Clin Oncol 23: 4913-4925, 2005 9. Sandgren AK, McCaul KD: Short-term effects of telephone therapy for breast cancer patients. Health Psychol 22: 310-315, 2003[CrossRef][Medline]
10. Goodwin PJ, Black JT, Bordeleau LJ, et al: Health-related quality-of-life measurement in randomized clinical trials in breast cancer: Taking stock. J Natl Cancer Inst 95: 263-281, 2003 11. Helgeson VS, Cohen S, Schulz R, et al: Group support interventions for women with breast cancer: Who benefits from what? Health Psychol 19: 107-114, 2000[CrossRef][Medline] 12. Antoni MH, Lehman JM, Kilbourn KM, et al: Cognitive-behavioral stress management intervention decreases the prevalence of depression and enhances benefit finding among women under treatment for early-stage breast cancer. Health Psychol 20: 20-32, 2001[CrossRef][Medline] 13. Lepore SJ, Helgeson VS, Eton DT, et al: Improving quality of life in men with prostate cancer: A randomized controlled trial of group education interventions. Health Psychol 22: 443-452, 2003[CrossRef][Medline]
14. Stanton AL, Danoff-Burg S, Sworowski LA, et al: Randomized, controlled trial of written emotional expression and benefit-finding in breast cancer patients. J Clin Oncol 20: 4160-4168, 2002 15. Coyne JC, Kagee A: More may not be better in psychological interventions for cancer patients. Health Psychol 20: 458, 2001[Medline] 16. Redd WH: Behavioral research in cancer as a model for health psychology. Health Psychol 14: 99-100, 1995[CrossRef][Medline]
17. Helgeson VS, Cohen S, Schulz R, et al: Education and peer discussion group interventions and adjustment to breast cancer. Arch Gen Psychiatry 56: 340-347, 1999 18. Graves KD: Social cognitive theory and cancer patients' quality of life: A meta-analysis of psychosocial intervention components. Health Psychol 22: 210-219, 2003[CrossRef][Medline] 19. Hewitt M, Herdman R, Holland J: Meeting psychosocial needs of women with breast cancer. Washington, DC, The National Academies Press, 2004 20. Beslija S, Bonneterre J, Burstein H, et al: For the Central European Cooperative Group: Consensus on medical treatment of metastatic breast cancer. Breast Cancer Res Treat, 81, S1-S7, 2003 (suppl 1)
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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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