Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

 描述(申请人提供)：到2030年，癌症将超过心脏病成为美国的头号死因。这些患者可能会经历癌症及其治疗导致的无节制症状的负担，1-3会导致与健康相关的生活质量(HRQOL)下降。4-8实体瘤有他们自己的一套症状。为了优化症状管理，必须从“一刀切”的固定干预转变为针对个别患者量身定做的适应性干预。这种转变需要研究如何 将先前测试过的单一固定干预措施按顺序进行最佳安排，以及如何针对个别患者最好地执行从一种干预措施切换到另一种干预措施的决策规则。到目前为止，我们团队对乳腺癌和肺癌患者的工作已经显示出两种基于家庭的症状管理干预措施的有效性，即由朋友或家人照顾者提供或与朋友或家人一起提供的反射疗法和冥想练习。建议的多阶段干预将采用序贯多分配随机试验(SMART)设计。这两种循证疗法的可持续性和症状结果的改善将在第5-8周和第12周对331名患者进行基于能量分析的随访，并与对照组进行比较。具体目的是：1.比较反射疗法组和冥想训练组在第1-4周(第1个干预阶段)疲劳严重程度的主要结果和3个次要症状结果：MD Anderson症状清单中的单一总分，抑郁症状和焦虑，以确定：a)这些治疗的相对有效性；b)每个治疗的应答者和无应答者的特征。目的2.在第一个干预阶段对疲劳的反射疗法没有反应的患者中，确定在5-8周(第二干预阶段)期间冥想练习与继续接受反射疗法对疲劳程度和三种继发性症状结果的附加值。目的3.在第一个干预阶段对疲劳冥想训练没有反应的患者中，确定在5-8周(第二干预阶段)接受反射训练与继续进行冥想训练对疲劳的严重程度和三种继发性症状结果的价值。目的4.比较接受干预序列的两组患者和对照组在疲劳严重程度和3种次要症状结果方面的改善情况。目的5.探讨在第一个干预阶段观察到的哪些二元特征与第二个干预阶段和12周随访的最佳患者症状结局相关，从而为未来干预阶段排序的决策规则确定剪裁变量。通过对两种循证干预措施进行排序，拟议的研究将通过确定如何在癌症治疗期间最大限度地发挥症状管理的好处来影响研究和实践。

 DESCRIPTION (provided by applicant): By 2030, cancer will surpass heart disease as the leading cause of death in the United States. These patients are likely to experience the burden of unmanaged symptoms resulting from cancer and its treatment,1-3 leading to diminished health related quality of life (HRQOL).4-8 Solid tumors carry their own set of symptoms. In order to optimize symptom management, there must be a shift from fixed interventions "one size fits all" to adaptive interventions tailored to individual patients. This shift requires research on how to best arrange previously tested single fixed interventions into sequences and how to best operationalize the decision rules for switching from one intervention to another for individual patients. Our team's work to date with breast and lung cancer patients has shown efficacy for two home-based symptom management interventions, reflexology and meditative practices, delivered by or with friend or family caregivers. The proposed multi-staged interventions will be developed using the sequential multiple assignment randomized trial (SMART) design. The sustainability of use of these two evidence-based therapies and improvements in symptom outcomes will be tested during weeks 5-8 and at the week 12 follow-up of 331 patients based on power analysis, against a control group. The specific aims are: Aim 1. To compare the reflexology and meditative practices groups weeks 1-4 (1st intervention stage) on the primary outcome of fatigue severity and 3 secondary symptom outcomes: a single summed score from the MD Anderson symptom inventory, depressive symptoms, & anxiety, so as to determine: a) the relative effectiveness of these therapies; and b) the characteristics of responders and non-responders to each therapy. Aim 2. Among patients who do not respond to reflexology on fatigue during the first intervention stage, to determine the value added by meditative practices during weeks 5-8 (2nd intervention stage) vs continuing with reflexology alone for severity of fatigue and the 3 secondary symptom outcomes. Aim 3. Among patients who do not respond to meditative practices on fatigue during the first intervention stage, to determine the value added by reflexology during weeks 5-8 (2nd intervention stage) vs continuing with meditative practices alone for severity of fatigue and the 3 secondary symptom outcomes. Aim 4. To compare improvements in fatigue severity and the 3 secondary symptom outcomes among two groups that received intervention sequences and the control group. Aim 5. To explore which dyadic characteristics observed during the first intervention stage are associated with optimal patient symptom outcomes during the 2nd intervention stage and week 12 follow-up, so as to determine tailoring variables for the decision rules of sequencing future intervention stages. By sequencing two evidence-based interventions, the proposed research will impact research and practice by determining how to maximize the benefit of symptom management during cancer treatment.