Tele-based Psychosocial Intervention for Symptom Management & HRQOL in Men Living

描述（申请人提供）：基于远程的心理社会干预对晚期前列腺癌患者症状管理和HRQOL的影响这5年评估了为期10周的基于视频电话的认知行为压力管理干预的效果（Tele-CBSM）对初次诊断时接受激素治疗（HT）的晚期前列腺癌（APC）男性的症状负担，或HT伴既往放疗（RT）。APC是慢性的，使人衰弱，存活率约为32%，少数民族的存活率甚至更低。大多数（70%）被诊断患有APC的男性接受HT以控制进展，并且患有区域性晚期APC的男性也接受RT。HT与副作用相关，包括抑郁、疲劳、潮热以及性和泌尿功能障碍，而RT还导致疲劳、刺激、泌尿功能障碍等。不可预测的病程）显著恶化健康相关生活质量（HRQOL）。然而，关于心理社会因素如何影响症状负担或心理社会干预在减轻症状负担和改善HRQOL方面的疗效的信息有限。此外，内分泌和免疫功能的心理社会调节与癌症患者（包括晚期癌症患者）的症状和HRQOL相关。压力相关的昼夜皮质醇中断可以促进炎症，从而加重症状（例如，疲劳、抑郁、疼痛）。在我们的试点工作中，我们观察到基于音频的远程CBSM改善了社会和身体功能，并减少了APC的症状负担。此外，远程CBSM的目标（例如，应对技能）解释了症状的减轻，而炎性细胞因子（例如，IL-1、IL-6）和皮质醇调节增强与抑郁、疼痛、泌尿功能障碍和疲劳等症状的减轻有关。我们建议提供一种增强的远程CBSM干预，以（a）利用新技术，使用视频会议为难以接触和种族多样化的患者，（B）纳入症状调节和管理的神经免疫模型，和（c）在200名患有APC的男性患者的多种族样本中测试Tele-CBSM的功效，所述男性患者经历HT或HT与先前的RT。CBSM组干预或健康促进组（远程HP）控制条件。我们的主要目的是确定相对于Tele-HP，Tele-CBSM的随机化与以下方面相关的程度：（目的1）改善症状负担管理和HRQOL，（目的2）减少痛苦和人际关系中断，并改善压力管理技能，以及（目的3）改善神经免疫调节（即，正常化的昼夜皮质醇和炎性细胞因子的减少）。我们还将测试（目标4）一组假设的途径（例如，远程- CBSM驱动的痛苦变化，压力管理技能，神经免疫调节等）这解释了分组与我们的症状负担和HRQOL的主要结果之间的关联。这是一项2x 3随机化实验设计，条件（Tele-CBSM vs. Tele-HP）作为组间因素，时间（基线[T1]，6个月）作为组间因素。基线后[T2]和12个月。基线后[T3]）作为组内因素。 公共卫生相关性：相关性：晚期前列腺癌（APC）的激素治疗（HT）是最常用的治疗方法，其特征在于情感和身体上损害治疗相关的副作用，包括疲劳、抑郁、潮热、疼痛、性/泌尿功能障碍等，因此给APC患者及其家人带来了重大负担。本研究将通过测试视频电话提供的基于小组的干预（Tele-CBSM）针对APC症状，使用全面的压力管理方法，将达到广泛的难以达到和种族多样化的人群，为APC的管理和减少症状负担提供信息。描绘路径（例如，压力管理技能，神经免疫调节），解释远程CBSM对症状负担的影响，将提供更好的理解机制，将心理和生理过程与症状管理联系起来，这是基于证据的，可以指导严重研究不足的PC患者亚组的心理治疗。

DESCRIPTION (provided by applicant): Tele-based Psychosocial Intervention for Symptom Management & HRQOL in Men Living with Advanced Prostate Cancer This 5-year evaluates the effects of a 10-week group-based videophone delivered cognitive-behavioral stress management intervention (Tele-CBSM) on symptom burden in men with advanced prostate cancer (APC) at initial diagnosis undergoing hormonal therapy (HT), or HT with prior radiotherapy (RT). APC is chronic and debilitating with survival rates about 32% and even lower rates for ethnic minorities. Most (70%) men diagnosed with APC receive HT to control progression and men with regionally advanced APC also undergo RT. HT is associated with side effects including depression, fatigue, hot flashes, and sexual and urinary dysfunction, while RT also leads to fatigue, irritation, urinary dysfunction, etc. Symptoms combined with challenges of living with advanced disease (e.g., unpredictable disease course) significantly deteriorate health- related quality of life (HRQOL). Yet, there is limited information on how psychosocial factors impact symptom burden, or on the efficacy of psychosocial interventions in reducing symptom burden and improving HRQOL. Furthermore, psychosocial modulation of endocrine and immune function is associated with symptoms and HRQOL in cancer patients, including those with advanced disease. Stress-related disruption in diurnal cortisol can promote inflammation that can exacerbate symptoms (e.g., fatigue, depression, pain). In our pilot work we observed that audio-based Tele-CBSM improves social and physical functioning, and decreases symptom burden in APC. Moreover, targets of Tele-CBSM (e.g., coping skills) explain reductions in symptoms, whereas decreases in inflammatory cytokines (e.g., IL-1, IL-6) and enhanced cortisol regulation are associated with decreases in symptoms such as depression, pain, urinary dysfunction and fatigue. We propose to deliver an enhanced Tele-CBSM intervention to (a) capitalize on new technology using a video-conferencing for hard-to- reach and ethnically diverse patients, (b) incorporate a neuroimmune model of symptom regulation and management, and (c) test the efficacy of Tele-CBSM in a multi-ethnic sample of 200 men living with APC undergoing HT or HT with prior RT. Men will be randomized to a Tele-CBSM group intervention or a health promotion group (Tele-HP) control condition. Our primary aims are to determine the extent to which randomization to Tele-CBSM relative to Tele-HP is associated with: (Aim 1) improved symptom burden management and HRQOL, (Aim 2) reduced distress and interpersonal disruption, and improved stress management skills, and (Aim 3) improved neuroimmune regulation (i.e., normalized diurnal cortisol & decreases in inflammatory cytokines). We will also test (Aim 4) a set of hypothesized pathways (e.g., Tele- CBSM driven changes in distress, stress management skills, neuroimmune regulation, etc.) that explain the association between group assignment and our primary outcomes of symptom burden and HRQOL. This is a 2x3 randomized experimental design with condition (Tele-CBSM vs. Tele-HP) as the between groups factor and time (baseline [T1], 6-mos. post-baseline [T2], & 12-mos. post-baseline [T3]) as the within groups factor. PUBLIC HEALTH RELEVANCE: Relevance: Hormonal therapy (HT) for advanced prostate cancer (APC) is the most commonly available treatment and is characterized by emotionally and physically compromising treatment-related side effects including fatigue, depression, hot flashes, pain, sexual/urinary dysfunction, etc. thus presenting a significant burden to APC patients and their families. This study will provide information for the management of APC and reduction of symptom burden by testing a videophone-delivered group-based intervention (Tele-CBSM) targeting APC symptoms using a comprehensive stress management approach that will reach a broad hard to reach and ethnically diverse population. Delineating pathways (e.g., stress management skills, neuroimmune regulation) that explain the effects of Tele-CBSM on symptom burden will provide a better understanding of mechanisms that link psychosocial and physiological processes to symptom management that is evidence- based and can guide psychosocial treatments in a critically understudied subgroup of PC patients.