Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use

非正式的照顾者，通常是家庭成员或朋友，提供了5.7所需的一半以上的照顾。 在美国，有100万癌症幸存者，通常会对健康产生负面影响。至少30%的 幸存者和他们的照顾者报告心理困扰（抑郁和焦虑），这种困扰可能 干扰最佳症状管理。这项研究将支持幸存者-照顾者的两个成员 在幸存者的癌症和治疗相关症状的管理和二分之一的 心理困扰设计：采用序贯多重分配随机试验（SMART） 设计，一个更新的适应性设计。SMART超越了传统的RCT，采用精确的方法， 以正确的剂量和正确的顺序为正确的幸存者-照顾者二分体确定正确的治疗。我们 将使用两种循证干预措施：症状管理工具包（SMT）和电话人际关系 咨询（TIP-C）。虽然我们已经建立了这些干预措施的总体疗效，但个体差异 在回应中。当干预最初不起作用时，临床逻辑是延长时间表， 采取不同的干预措施。然而，这些替代办法很少经过测试，也没有证据。但他们 将在这项研究中。样本：我们将招募298名抑郁或焦虑程度升高的幸存者， 正在接受实体瘤化疗或靶向治疗的患者及其298名护理人员。程序：二人组 最初将随机分配至单独SMT或TIP-C +SMT。如果幸存者的高度抑郁或焦虑 在第4周之前，单独使用SMT没有反应，将对二联体进行重新随机化，以继续使用SMT，以给予更多时间，或 TIP-C+SMT。将在基线、第13周（干预后）和第17周（随访）收集结局数据。 第1-12周期间的评估将记录症状、干预接收、制定和 忠诚具体目标：1）确定TIP-C+SMT中的二元组与单独创建的SMT组相比是否 到第一次随机分组时，将具有：a）较低的抑郁、焦虑和13种其他症状的总严重程度 在第1-12、13和17周（主要结局）; B）医疗保健服务的使用减少（住院、紧急 护理或急诊科[艾德]就诊）（次要结果）; c）更大的自我效能， 在第13周和第17周期间，社会支持和较低的照顾者负担（潜在中介）。2)在非- 4周后，单独使用SMT的应答者，确定分配至TIP-C+SMT的二元组与分配至TIP-C+SMT的二元组相比， 通过第二次随机化创建的SMT单独组将具有更好的主要和次要结局， 第5-12、13和17周时的潜在介质。3)测试幸存者和照顾者的相互依赖性 主要和次要结果。4)确定二分体的哪些特征与 在第1-4周期间对单独SMT的反应和在第1-12周、第13周期间对二分体的最佳结果， 17，以确定个性化干预排序决策规则的定制变量。 研究结果将用于改善症状管理和减少痛苦的幸存者-照顾者的二人组。

Informal caregivers, typically family members or friends, provide more than half of the care needed for the 5.7 million cancer survivors in the United States, often with negative health consequences. At least 30% of survivors and their caregivers report psychological distress (depression and anxiety) and such distress may interfere with optimal symptom management. This study will support both members of the survivor-caregiver dyad in the management of the survivor's cancer- and treatment-related symptoms and the dyad's psychological distress. Design: We will use the sequential multiple assignment randomized trial (SMART) design, a newer adaptive design. The SMART moves beyond a traditional RCT to a precision approach to determine the right treatment at the right dose with the right sequence for the right survivor-caregiver dyad. We will use two evidence-based interventions: Symptom Management Toolkit (SMT) and Telephone Interpersonal Counseling (TIP-C). While we have established the overall efficacy of these interventions, but individuals differ in responses. When an intervention does not initially work, clinic logic is to either extend the timeframe or prescribe a different intervention. Yet, such alternatives are seldom tested nor evidence-based. However, they will be in this study. Sample: We will enroll 298 survivors with elevated depression or anxiety who are undergoing chemotherapy or targeted therapy for a solid tumor and their 298 caregivers. Procedure: Dyads will be initially randomized to SMT alone or TIP-C +SMT. If the survivor's elevated depression or anxiety does not respond to SMT alone by week 4, dyads will be re-randomized to continue with SMT to give it more time or to TIP-C+SMT. Outcome data will be collected at baseline, weeks 13 (post-intervention) and 17 (follow-up). Assessments during weeks 1-12 will document changes in symptoms, intervention receipt, enactment and fidelity. Specific aims: 1) Determine if dyads in the TIP-C+SMT as compared to the SMT alone group created by the first randomization will have: a) lower depression, anxiety, and summed severity of 13 other symptoms at weeks 1-12, 13, and 17 (primary outcomes); b) lower use of healthcare services (hospitalizations, urgent care or emergency department [ED] visits) during 17 weeks (secondary outcomes); c) greater self-efficacy, social support, and lower caregiver burden during weeks 13 and 17 (potential mediators). 2) Among non- responders to the SMT alone after 4 weeks, determine if dyads assigned to TIP-C+SMT as compared to the SMT alone group created by the second randomization will have better primary and secondary outcomes and potential mediators at weeks 5-12, 13, and 17. 3) Test the interdependence in survivor's and caregiver's primary and secondary outcomes. 4) Determine which characteristics of the dyad are associated with responses to the SMT alone during weeks 1-4 and optimal outcomes for the dyad during weeks 1-12, 13 and 17 so as to determine tailoring variables for the decision rules of individualized sequencing of interventions. Findings will be used to improve symptom management and reduce distress in survivor-caregiver dyads.