RCT of a psychological intervention for patients with cancer: I. Mechanisms of change.

Abstract

Little is known about the therapeutic processes contributing to efficacy of psychological interventions for patients with cancer. Data from a randomized clinical trial yielding robust biobehavioral and health effects (B. L. Andersen et al., 2004Andersen et al., , 2007 were used to examine associations between process variables, treatment utilization, and outcomes. Novel findings emerged. Patients were highly satisfied with the treatment, but their higher levels of felt support (group cohesion) covaried with lower distress and fewer symptoms. Also, specific. treatment strategies were associated with specific outcomes, including lower distress, improved dietary habits, reduced symptomatology, and higher chemotherapy dose intensity. These data provide a comprehensive test of multiple therapeutic processes and mechanisms for biobehavioral change with an intervention including both intensive and maintenance phases. Keywordsprocess; therapy; cancer; compliance; dose intensity Psychological interventions for patients with cancer are largely effective in reducing the many burdens and sequelae of the disease and treatment. Interventions can improve emotional adjustment and quality of life, with selected demonstrations of positive health and immune outcomes (Andersen, 2002;Meyer & Mark, 1995). Despite this, little is known about the therapeutic events or processes that lead to or are responsible for therapeutic change and the durability of such change. Kazdin (2006) noted that evaluating mechanisms is important for many reasons. Data on mechanisms can bring order to the variety of treatments available, provide explanations of the broad effects of therapy, enhance translation of treatments to clinical practice, assist in the identification of treatment moderators, and facilitate understanding of therapeutic change. We discuss the influence of process variablessatisfaction with the treatment and feelings of cohesion-and the relationship between utilization of intervention techniques and treatment outcomes. Necessarily, we also draw on the psychotherapy outcome research literature.Patient satisfaction with treatment is a singularly important goal, but it may also be important because it is influential to patients' involvement intreatment (Dearing, Barrick, Dermen, & Walitzer, 2005) and, in turn, treatment efficacy. For group psychotherapy patients, treatment satisfaction has been associated with willingness to participate (Perrone & Sedlacek, 2000). It is important to note that studies with both psychotherapy and primary care outpatients have identified associations between satisfaction and adherence, including appointment keeping (Dearing et al., 2005), compliance with treatment recommendations (Hirsh et al., 2005), and medication use (Barfod et al., 2005). When asked, patients with cancer are typically satisfied with what psychological interventions have to offer (Petersson, Berglund, Brodin, Glimelius, & Sjoden, 2000;Manne et al., 2007). More specific questions have found that, among interventions that includ...

Host Factors and Cancer Progression: Biobehavioral Signaling Pathways and Interventions

“…84 In one randomized clinical trial of cognitive behavioral stress management, distress, social disruption, and cortisol decreases were paralleled by increased confidence in using relaxation as a coping strategy to manage stress, 75,88 findings that mirror those of others conducting trials of cognitive behavioral interventions and MBSR. 87,90 In addition to alterations in stress responses, it is also essential to consider whether the women who received psychological interventions in these trials successfully changed their health behaviors (eg, more exercise, better nutrition, less alcohol consumption, better adherence to hormonal medications and attendance at follow-up appointments) and actually got more effective medical treatment (eg, cointervention effects), 71 and if these changes conferred greater protection against disease progression and facilitated general health. Nevertheless, such positive side effects of psychological interventions would contribute a net beneficial effect for the care of patients with cancer.…”

Systems Modeling in Integrative Oncology

“…What is important is that treatment and follow-up compliance have been reported to be significantly worse in patients experiencing distressful psychosocial symptoms. [35][36][37] It is quite possible that treatment outcomes could be reduced in these patients as a consequence. The IOSM not only demonstrates the complex relationships that modulate these psychosocial symptoms, but it also highlights how various therapies may help in mitigating them.…”

Finding what is not there

“…The differences that were claimed by Andersen et al 1 were based on analyses that capitalized on chance and overfit the data to such an extent that the results were not interpretable. Moreover, across previous articles that reported the results from this trial, 3,4 there was an inconsistent specification of endpoints without the identification of which results were primary, and there was selective reporting of results to build the case that the intervention was largely effective despite considerable evidence to the contrary. Andersen et al 1 The difference in median time to recurrence was small (6 months) given the range of time to event in the intervention group (range, 0.9-11.8 years) and the control group (range, 0.2-12.0 years).…”

“…Overall, the trial was characterized by weak, inconsistent findings with a pattern that likely would not have been predicted a priori and that are difficult to make sense of post hoc. Nonetheless, a subsequent article 4 declared that the intervention yielded biobehavioral and health effects that were robust. In the current study, were recurrence and survival the primary endpoints?…”