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

非正式的照顾者，通常是家人或朋友，提供了5.7人所需的一半以上的护理 美国有数以百万计的癌症幸存者，往往会对健康造成负面影响。至少30% 幸存者和他们的照顾者报告了心理痛苦(抑郁和焦虑)，这种痛苦可能 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 DYAD在幸存者癌症和治疗相关症状以及DYAD的管理中的作用 心理上的痛苦。设计：我们将采用序贯多分配随机试验(SMART) 设计，一种较新的适应性设计。SMART超越了传统的RCT，而是一种精确的方法 根据正确的幸存者-照顾者二元组的正确顺序，以正确的剂量确定正确的治疗。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)。虽然我们已经确定了这些干预措施的总体效果，但个人情况有所不同 在回应中。当干预最初不起作用时，临床逻辑是要么延长时间框架，要么 制定一种不同的干预措施。然而，这样的替代方案很少经过测试，也很少有证据。然而，他们 将会出现在这项研究中。样本：我们将招募298名抑郁症或焦虑症加重的幸存者 接受实体肿瘤化疗或靶向治疗的患者和他们的298名照顾者。操作步骤：二人组 最初将随机分为SMT组或TIP-C+SMT组。如果幸存者升高的抑郁或焦虑 在第4周之前不单独对SMT作出反应，将重新随机选择继续进行SMT，以便给它更多时间或 至TIP-C+SMT。结果数据将在基线、第13周(干预后)和第17周(随访)收集。 第1-12周的评估将记录症状、干预收据、实施和 富达。具体目标：1)确定与单独创建的SMT组相比，TIP-C+SMT组中的DUADS是否 通过第一次随机分组将会有：a)较低的抑郁、焦虑和其他13种症状的综合严重程度 在第1-12周、第13周和第17周(主要结果)；b)较少使用医疗服务(住院，紧急 护理或急诊科就诊)(次要结果)；c)更高的自我效能， 社会支持，以及第13周和第17周期间较低的照顾者负担(潜在调解人)。2)在非 4周后，只接受SMT的应答者，确定分配给TIP-C+SMT的DUADS与 由第二次随机产生的单纯SMT组将有更好的一次和二次结果 5-12周、13周和17周的潜在调解人测试幸存者和照顾者之间的相互依赖 主要和次要结果。4)确定二分体的哪些特征与 在1-4周仅对SMT的反应和在1-12、13和 17以确定干预措施个别化排序决策规则的调整变量。 研究结果将用于改善症状管理，减少幸存者-照顾者双方的痛苦。

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.