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

描述(由申请人提供)：晚期前列腺癌患者症状管理和高质量生活质量的远程心理社会干预这项为期5年的研究评估了为期10周的基于小组的视频电话传递的认知-行为压力管理干预(TELE-CBSM)对接受激素治疗(HT)或接受过放射治疗(RT)的晚期前列腺癌(APC)患者初始诊断时症状负担的影响。APC是慢性的，使人虚弱，存活率约为32%，少数民族的存活率甚至更低。大多数(70%)被诊断为APC的男性接受了高血压治疗以控制病情进展，而地区性晚期APC患者也接受了RT。羟色胺与抑郁、疲劳、潮热、性功能障碍和尿路功能障碍等副作用有关，而放疗也会导致疲劳、刺激、排尿功能障碍等。症状与晚期疾病生活的挑战(如不可预测的病程)显著恶化与健康相关的生活质量(HRQOL)。然而，关于心理社会因素如何影响症状负担，或者关于心理社会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心理社会调节与癌症患者的症状和HRQOL有关，包括那些晚期疾病患者。与应激相关的昼夜皮质醇中断会促进炎症，从而加剧症状(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Tele-CBSM改善了APC的社会和身体功能，并减少了症状负担。此外，Tele-CBSM的目标(例如，应对技能)解释了症状的减少，而炎症细胞因子(例如，IL-1、IL-6)的减少和皮质醇调节的增强与抑郁、疼痛、排尿功能障碍和疲劳等症状的减少有关。我们建议提供一种增强的Tele-CBSM干预措施，以(A)利用新技术，为难以接触到的和种族多样化的患者使用视频会议，(B)纳入症状调节和管理的神经免疫模型，以及(C)在200名患有APC的多民族男性样本中测试Tele-CBSM的有效性。男性将被随机分成Tele-CBSM组干预组或健康促进组(Tele-HP)对照组。我们的主要目标是确定Tele-CBSM相对于Tele-HP的随机化程度与：(目标1)改善症状负担管理和HRQOL，(目标2)减少痛苦和人际干扰，改善压力管理技能，以及(目标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)一组假设的路径(例如，Tele-CBSM驱动的痛苦变化、压力管理技能、神经免疫调节等)。这解释了小组分配与症状负担和HRQOL的主要结果之间的关联。这是一项2x3随机实验设计，以条件(Tele-CBSM与Tele-HP)为组间因素和时间(基线[T1]，6-mos)。基线后[T2]和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.