PSYCHOIMMUNE OUTCOMES: INTERVENTION IN BREAST CANCER

这项研究的具体目的是(1)检查为新诊断的乳腺癌患者提供的为期8周的综合支持计划的免疫学、心理社会和临床症状结果，以及(2)确定支持计划是否对持续低和高基线自然杀伤细胞(NK)活性模式(低于和高于中位数NK活性x 2)的患者具有不同的效果。综合支持计划包括每周压力管理和社会支持计划，以及每周三次的运动训练活动。背景和意义：癌症的诊断和治疗是巨大的心理、情感和身体痛苦的主要来源。以前的大多数干预措施都受到单一方法的限制(心理或身体支持，而不是两者兼而有之)，以及缺乏免疫学评估。鉴于身心互动在人类功能中的重要性，一种同时提供心理和身体支持的综合方法将最有利于帮助处于困境中的患者。此外，有迹象表明，基线NK活性模式低的乳腺癌患者预后比基线NK活性模式高的乳腺癌患者差。对综合方法的全面检查将为提高新诊断乳腺癌患者的生活质量提供见解。设计和方法：采用纵向实验设计，包括前测和后测，90名新诊断的I-IV期乳腺癌患者将按疾病分期(I-IIB期与局部进展期)进行分层，并随机分配到试验组(干预)或对照组(等待名单)。在开始干预之前，将对NK活性进行两次检查，以确定NK活性的模式。干预将在化疗或放射治疗开始时开始。干预后的数据将在干预后立即收集，并在干预开始后的6个月和12个月收集，与患者的常规诊所就诊时间一致。依赖测量和分析：将测量干预对免疫反应(NK活性和数量、淋巴因子激活的杀伤细胞活性、IL-1α、IL-2和干扰素-γ)、心理社会健康(痛苦、情绪状态和生活质量)以及临床症状(疲劳、恶心、呕吐和睡眠)的影响。结果变量的重复测量将使用纵向数据分析方法，而单变量分析将使用2样本t检验或非参数Wilcoxon秩和检验。

The specific aims of this study are (1) to examine immunological, psychosocial, and clinical symptom outcomes of an 8-week integrated support program for patients with newly diagnosed breast cancer, and (2) to determine whether the support program has differential effects on patients with persistently low versus high baseline natural killer cell (NK) activity pattern (below versus above median NK activity x 2). The integrated support program includes 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 significant psychological, emotional, and physical distress. Most previous interventions have been limited by a unidimensional approach (psychosocial or physical support, not both), and by the lack of immunological assessments. Given the importance of mind-body interactions in human functioning, an integrated approach of concurrent psychological and physical support will be most beneficial to assist patients in distress. Further, there is indication that breast cancer patients with lower baseline NK activity pattern have a poorer prognosis than those with higher baseline NK activity pattern. A comprehensive examination of an integrated approach will provide insights to improving quality of life for patients with newly diagnosed breast cancer. Design and Method: Using a longitudinal, experimental design with pretest and posttest, 90 patients with stage I-IV newly diagnosed breast cancer will be stratified by disease stage (I-IIB vs. locally advanced) and randomly assigned to the Experimental (intervention) or Control (wait-list) group. NK activity will be examined twice prior to the beginning of intervention to determine the pattern of NK activity. The intervention will begin at the start of chemo- or radiotherapy. Post-intervention data will be collected immediately after intervention and at 6 and 12 months from the initiation of intervention, coinciding with patients' routine clinic visits. Dependent Measures and Analysis: The impact of intervention will be measured on immune responses (NK activity and number, lymphokine activated killer cell activity, IL-1alpha, IL-2 and interferon-gamma), psychosocial well-being (distress, mood states, and quality of life), and clinical symptoms (fatigue, nausea, vomiting, and sleep). Longitudinal data analysis methods will be employed to analyze repeated measures of outcome variables, whereas 2-sample t-test or nonparametric Wilcoxon rank-sum test will be used to perform univariate analysis.