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

描述（由申请方提供）：基于远程心理社会干预的晚期前列腺癌患者症状管理和HRQOL的效果。本研究评估了10周基于可视电话的认知行为压力管理干预（Tele-CBSM）对早期诊断接受激素治疗（HT）或HT加放疗（RT）的晚期前列腺癌（APC）患者症状负担的影响。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%）确诊为APC的男性接受激素治疗以控制病情进展，局部晚期APC的男性也接受激素治疗。激素治疗的副作用包括抑郁、疲劳、潮热、性功能和尿功能障碍，而激素治疗还会导致疲劳、刺激、尿功能障碍等。症状与疾病晚期生活的挑战（例如，不可预测的病程）相结合，显著恶化了与健康相关的生活质量（HRQOL）。然而，关于社会心理因素如何影响症状负担，或社会心理干预在减轻症状负担和改善HRQOL方面的有效性的信息有限。此外，内分泌和免疫功能的社会心理调节与癌症患者（包括晚期癌症患者）的症状和HRQOL相关。与压力相关的昼夜皮质醇紊乱可促进炎症，从而加重症状（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APC的社交和身体功能，并减轻了症状负担。此外，远程cbsm的目标（如应对技能）解释了症状的减轻，而炎症细胞因子（如IL-1、IL-6）的减少和皮质醇调节的增强与抑郁、疼痛、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)利用视频会议的新技术，为难以接触和种族多样化的患者提供服务，(b)结合症状调节和管理的神经免疫模型，以及(c)在200名患有APC的男性患者中测试远程cbsm的疗效，这些患者正在接受HT或有过rt。男性将被随机分配到远程cbsm组干预或健康促进组（Tele-HP）控制条件。我们的主要目的是确定远程- cbsm相对于远程- hp的随机化在多大程度上与以下因素相关：（目标1）改善症状负担管理和HRQOL；（目标2）减少痛苦和人际关系破坏，改善压力管理技能；（目标3）改善神经免疫调节（即，正常的每日皮质醇和炎症细胞因子的减少）。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），这些途径解释了组分配与我们的症状负担和HRQOL的主要结果之间的关联。这是一个2 × 3随机实验设计，以条件（Tele-CBSM vs. Tele-HP）作为组间因素和时间（基线[T1]， 6个月）。基线后[T2]， & 12个月。基线后[T3])作为组内因素。

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.