Significant Reduction in Breast Cancer Recurrence and Mortality With Psychologic Intervention News Author: Nick Mulcahy CME Author: Hien T. Nghiem, MD In a study with a median follow-up of 11 years, breast cancer patients with stage II disease randomized to psychologic intervention had a significantly lower risk for recurrence and death than patients who did not receive the intervention. The study was published online on November 17 in Cancer and is scheduled for publication in the December 15 print edition of the journal. Dr. Andersen believes that the intervention — which used empirically supported methods for improving mood, coping effectively, and altering health behaviors — could be effectively used in patients with all types of cancer. The intervention consisted of 26 group-therapy and education sessions during a 1-year period after surgery and before the start of adjuvant cancer therapies. "The intervention is not just social support. Social support isn't enough. Patients need real skills and methods to change their minds and cope," she said. "The intervention was powerful because we used empirically supported tools." Previous studies have reported inconsistent results with psychologic interventions and breast cancer, Dr. Andersen said. "Four of the trials were in metastatic patients and did not show survival benefit, which might be expected. We purposely chose stage II patients — and not stage I or metastatic patients — because variability [in outcome at about 10 years] would allow us to see an effect." Dr. Andersen hopes that the study's surprising results spur "active lobbying" to get insurance reimbursement for such interventions. The intervention "is the kind of thing that is a considered a frill in most clinical settings. But our study shows significant health benefits," she said. Impressive Results In the study of 227 women with a median follow-up of 11 years, disease recurred in 62 women. The median time to recurrence for those in the intervention group was 2.8 years, compared with 2.2 years for those in the assessment group, who only received a psychologic assessment. In multivariate analyses that accounted for a wide range of variables, such as prognostic factors at diagnosis, age, and type of surgery, the intervention group had a 45% lower risk for disease recurrence than the assessment group. For the 44 patients who died of breast cancer, the median survival time was 6.1 years for the intervention group and 4.8 years for the assessment group. The intervention group had a 56% lower risk for breast cancer death. Both the recurrence and mortality-risk differences were statistically significant. The researchers also conducted 2 post hoc analyses. The first analysis looked at all-cause mortality. Among those 54 patients in the study who died, the median survival time was 6.0 years for the intervention group and 5.0 years for the assessment group. The intervention group had a 49% lower risk for all-cause mortality, which was statistically significant. The second analysis looked at the drop-out rate in the study, which was defined as those in the intervention group having attended less than 20% of the sessions. "The drop-out rate was exceedingly low — 14%. Usually, intervention studies in cancer patients have twice the drop-out rate," said Dr. Andersen. The researchers recalculated the recurrence and mortality rates among the patients who stayed in the study and the risk reduction grew larger, with the intervention group having a 50% lower risk for disease recurrence and a 68% lower risk for death than the assessment group. "Clinical-trials analysts may commonly exclude patients who received little or none of the treatment being studied with the perspective that a more accurate view of the specific efficacy of the treatment is then provided," write Dr. Andersen and her colleagues at Ohio State University. Daily Muscle Relaxation and Stress Mindfulness: Keys? The psychologic intervention was provided in small groups, ranging from 8 to 12 patients, that were led by 2 psychologists. The intensive phase of the therapy was 4 months of weekly sessions, which was followed by a maintenance phase of 8 monthly sessions. In total, 26 sessions (39 therapy hours) occurred over 12 months. The goal of the intervention was to reduce distress regarding a patient's breast cancer, improve quality of life, improve health behaviors (including diet, exercise, and smoking cessation), and facilitate cancer-treatment compliance and medical follow-up. The sessions provided tools and methods to help the patients, noted Dr. Andersen. "Patients with cancer need real, substantial strategies." Strategies included progressive muscle relaxation for stress reduction; problem solving for common difficulties, such as fatigue; identifying supportive family members or friends; using assertive communication to get needs met; employing ways to increase daily activity, such as walking; improving dietary habits; and coping with adverse treatment effects, such as nausea. Two elements of the intervention seem especially important in combination, suggest the authors. The patients who had the greatest reductions in distress and physical symptoms at 12 months were those who practiced daily progressive muscle relaxation and remembered daily that stress could adversely affect their health. "With progressive muscle relaxation, you tense and release muscles throughout the body. It takes 40 minutes to perform the exercise at first, but then you can eventually accomplish it in as little as 2 minutes," said Dr. Andersen. Inflammation Markers Measured Previous studies by Dr. Andersen and colleagues have shown that the year-long intervention program significantly improved psychological, behavioral, and health outcomes, and enhanced immunity. In this study, the researchers also report on markers of inflammation in 48 women in the study who had cancer recurrence. The women were compared with 48 women who did not have a return of their cancer. Data from a patient assessment 17 months before detection reveal that patients who had recurrence had significantly higher white blood cell, neutrophil, lymphocyte, and natural-killer cell counts, compared with disease-free patients. The patients with disease recurrence also had higher levels of cortisol, worse physical functioning, and fatigue. "A psychologic intervention that reduces stress could conceivably interrupt the inflammatory process, thereby mediating the intervention effect to limit disease progression," write the authors speculatively. The study was supported by the National Institute of Mental Health and the National Cancer Institute, with additional support from the American Cancer Society, Longaberger Company-American Cancer Society, US Army Medical Research Acquisition Activity, Ohio State University Comprehensive Cancer Center, and Walther Cancer Institute. The study authors have disclosed no relevant financial relationships. Cancer. 2008;113:3450-3458. Clinical Context Psychologic factors can have profound effects on health. Chronic stress negatively affects most systems because of prolonged exposure to catecholamines and glucocorticoids. It has been reported that for cancer patients, stress-related psychosocial factors have led to higher cancer incidence in initially healthy people, poorer survival in patients diagnosed with cancer, and higher cancer mortality rates. The question of whether stress poses a risk for cancer progression has been more difficult to answer. The aim of this study was to test the hypothesis that cancer patients coping with their recent diagnosis but receiving a psychologic intervention would have improved survival vs patients who were only assessed. Study Highlights A total of 227 patients who were surgically treated for regional breast cancer and awaiting adjuvant therapy participated in this study. Exclusion criteria included previous cancer diagnosis; refusal of cancer treatment; age younger than 20 years or older than 85 years; residence more than 90 miles from the research site; and diagnosis of mental retardation, severe or untreated psychopathologic disorder (eg, schizophrenia), neurologic disorders, dementia, or an immunologic condition/disease. Patients were assessed with psychologic and behavioral measures and had a health evaluation, and a 60-mL blood sample was taken. Patients were randomly assigned to 1 of 2 study groups: psychologic intervention plus assessment (n = 114) or assessment only (n = 113). At no time were there significant differences noted between the study groups. The intervention was psychologist led; conducted in small groups; and included strategies to reduce stress, improve mood, alter health behaviors, and maintain adherence to cancer treatment and care. A total of 26 sessions for 12 months was delivered. The endpoint measured was breast cancer recurrence and death. Results demonstrated that after a median of 11 years of follow-up, disease recurrence was reported to occur in 62 (29%) of 212 women, and death was reported for 54 (24%) of 227 women. 29 women in the intervention group and 33 in the assessment-only group had recurrence. The observed median time to recurrence for the intervention group was 2.8 years (range, 0.9 - 11.8 years) and for the assessment-only group, 2.2 years (range, 0.2 - 12 years). With regard to survival, of the women who died, 24 were in the intervention group and 30 were in the assessment-only group. The observed median survival time for the patients who died of breast cancer in the intervention group was 6.1 years (range, 1.0 - 8.1 years) vs 4.8 years (range, 0.4 - 8.9 years) for patients in the assessment-only group. With use of Cox proportional hazards analysis, patients in the intervention group were found to have a reduced risk for breast cancer recurrence (hazard ratio [HR], 0.55; P = .034) and death from breast cancer (HR, 0.44; P = .016) vs patients in the assessment-only group. Follow-up analyses also demonstrated that patients in the intervention group had a reduced risk for death from all causes (HR, 0.51; P = .028). Pearls for Practice For cancer patients, studies have shown that stress-related psychosocial factors have led to higher cancer incidence in initially healthy people, poorer survival in patients diagnosed with cancer, and higher cancer mortality rates. Psychologic interventions demonstrated a reduction in the risk for breast cancer recurrence, death, and risk for death from all causes. Source: Medscape.com Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.