The aims of this study are (1) to examine immunological, psychosocial, and symptom management outcomes of an 8-week integrated support program for patients with newly diagnosed or recurrent breast cancer, and (2) to determine whether the support program has differential effects on patients with persistently low natural killer cell (NK) activity pattern at baseline (below median NK activity x 2) and patients with persistently high NK activity pattern at baseline (above median NK activity x 2). The integrated support program will include weekly stress management and social support programs, and exercise training activities three times a week. Background and Significance: Cancer diagnosis and treatment are a major source of psychological, emotional, and physical distress. Most previous interventions have been limited by a unidimensional approach (psychosocial or physical support, but not both), and by the lack of immunological assessment. Previous research also suggests that breast cancer patients with low baseline NK activity pattern have a poorer prognosis, compared with those with higher baseline NK activity. Thus, we propose to provide and evaluate an integrated support program, comparing psychoimmunological and clinical outcomes between patients in the intervention vs. non-intervention groups and between patients with two different patterns of baseline NK activity. Design and Method: Using a longitudinal, experimental design with pretest and posttest, 90 patients with stage I-IV and recurrent breast cancer will be stratified by age, disease stage and treatment mode, and randomly assigned to the Experimental (intervention) or Control (wait-list) group. NK activity will be examined twice prior to the intervention to determine the pattern of NK activity. The intervention will begin at the start of chemotherapy. Post-intervention data will be collected immediately after 8-week intervention, and at 6 and 12 months from the initiation of intervention, coinciding with patients' routine clinical follow up schedules. Dependent Measures and Analysis: The impact of intervention will be measured on tumor-relevant immune responses (NK activity and number, lymphokine activated killer cell activity, IL-1alpha, IL-2 and interferon-gamma), psychosocial responses (distress, mood states, and quality of life), and symptom management (fatigue, nausea and vomiting, and sleep). Data will be analyzed using analysis of covariance, two sample t-tests or nonparametric Wilcoxon rank-sum tests, and Spearman and Pearson correlation coefficients.
