PSYCHOIMMUNE OUTCOMES--INTERVENTION IN BREAST CANCER

本研究的目的是（1）检查新诊断或复发乳腺癌患者的8周综合支持计划的免疫学、心理社会学和症状管理结果，以及（2）确定支持计划是否对基线时自然杀伤细胞（NK）活性持续低下的患者有不同的影响（低于中位NK活性x2）和基线时具有持续高NK活性模式的患者（高于中位NK活性x2）。 综合支持计划将包括每周的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心理、情感和身体痛苦的主要来源。大多数以前的干预措施受到单向度方法（心理社会或身体支持，但不是两者兼而有之）和缺乏免疫评估的限制。 先前的研究还表明，与基线NK活性较高的乳腺癌患者相比，基线NK活性较低的乳腺癌患者预后较差。 因此，我们建议提供和评估一个综合的支持计划，比较心理免疫学和临床结果之间的患者在干预与非干预组和患者之间的两种不同模式的基线NK活性。设计和方法：采用纵向实验设计，包括前测和后测，将90例I-IV期和复发性乳腺癌患者按年龄、疾病分期和治疗模式分层，并随机分配至实验（干预）组或对照（等待名单）组。 在干预前将检查NK活性两次，以确定NK活性的模式。 干预将在化疗开始时开始。 干预后数据将在8周干预后立即收集，并在干预开始后6个月和12个月收集，与患者的常规临床随访时间表一致。相关测量和分析：将测量干预对肿瘤相关免疫应答（NK活性和数量、淋巴因子激活的杀伤细胞活性、IL-1 α、IL-2和干扰素-γ）、心理社会应答（痛苦、情绪状态和生活质量）和症状管理（疲劳、恶心和呕吐以及睡眠）的影响。 将使用协方差分析、双样本t检验或非参数Wilcoxon秩和检验以及斯皮尔曼和皮尔逊相关系数分析数据。

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.