PSYCHOIMMUNE OUTCOMES--INTERVENTION IN BREAST CANCER

这项研究的目的是(1)检验为期8周的综合支持计划对初诊或复发乳腺癌患者的免疫学、社会心理和症状管理结果，以及(2)确定该支持计划对基线自然杀伤细胞(NK)活性持续低的患者(低于NK活性中值x 2)和NK活性持续高的患者(高于NK活性中值x 2)是否有不同的效果。综合支持计划将包括每周压力管理和社会支持计划，以及每周三次的锻炼训练活动。背景和意义：癌症的诊断和治疗是心理、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维方法的限制(心理或身体支持，但不是两者都有)，以及缺乏免疫学评估。以往的研究也表明，与基线NK活性较高的乳腺癌患者相比，基线NK活性低的乳腺癌患者预后较差。因此，我们建议提供并评估一项综合支持计划，比较干预组和非干预组患者之间以及具有两种不同基线NK活性模式的患者之间的心理免疫学和临床结果。设计与方法：采用纵向、前后测的实验设计，将90例I~IV期复发乳腺癌患者按年龄、疾病分期、治疗方式分层，随机分为干预组和对照组。干预前将对NK活性进行两次检测，以确定NK活性的模式。干预将在化疗开始时开始。干预后的数据将在干预8周后立即收集，并在干预开始后的6个月和12个月收集，与患者的常规临床随访时间表一致。依赖测量和分析：将测量干预对肿瘤相关免疫反应(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)、心理社会反应(痛苦、情绪状态和生活质量)以及症状处理(疲劳、恶心和呕吐以及睡眠)的影响。数据将使用协方差分析、两个样本t检验或非参数Wilcoxon秩和检验以及Spearman和Pearson相关系数进行分析。

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.