Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

使用 SMART 设计改进癌症患者的症状管理策略

• 批准号: 9191344
• 负责人: Alla Sikorskii
• 金额: $ 55.6万
• 依托单位: MICHIGAN STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-12-08 至 2019-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9191344
• 关键词: Anxiety; Cancer Intervention; Cancer Patient; Caregivers; Cause of Death; Characteristics; Clinical; Complementary therapies; Control Groups; Equipment and supply inventories; Evidence based intervention; Family Caregiver; Fatigue; Friends; Future; Group Practice; Heart Diseases; Home environment; Individual; Intervention; Logic; Malignant Neoplasms; Malignant neoplasm of lung; Meditation; Outcome; Patients; Public Health; Randomized; Randomized Clinical Trials; Reflexology; Research; Severities; Solid Neoplasm; Sum; Symptoms; Testing; Time; Translations; United States; Work; base; cancer therapy; clinical practice; depressive symptoms; evidence base; experience; follow-up; group intervention; health related quality of life; individual patient; malignant breast neoplasm; power analysis; primary outcome; public health relevance; randomized trial; relative effectiveness; response; symptom management; symptomatic improvement; trial design

 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.

 描述（由申请人提供）：到2030年，癌症将超过心脏病成为美国的主要死因。这些患者可能会经历由癌症及其治疗引起的未受控制的症状负担，1-3导致健康相关生活质量（HRQOL）下降。4 -8实体瘤有自己的一组症状。为了优化症状管理，必须从“一刀切”的固定干预措施转变为针对个体患者的适应性干预措施。这种转变需要研究如何 最好地将先前测试的单一固定干预措施安排到序列中，以及如何最好地操作决策规则，以便针对个体患者从一种干预措施切换到另一种干预措施。迄今为止，我们团队对乳腺癌和肺癌患者的工作表明，两种基于家庭的症状管理干预措施，反射疗法和冥想练习，由朋友或家庭护理人员提供或与朋友或家庭护理人员一起提供，具有疗效。将使用序贯多分配随机试验（SMART）设计开发拟定的多阶段干预措施。在第5-8周和第12周随访期间，将根据功效分析对331例患者与对照组进行对比，以检验这两种循证疗法的可持续性和症状结局的改善。具体目标是：目标1。比较反射疗法组和冥想练习组第1-4周（第1个干预阶段）的疲劳严重程度主要结局和3个次要症状结局：MD安德森症状量表、抑郁症状和焦虑的单个总分，以确定：a）这些疗法的相对有效性;和B）每种疗法的应答者和非应答者的特征。目标二。在第一个干预阶段对反射疗法对疲劳无反应的患者中，确定在第5-8周（第二个干预阶段）冥想练习与继续单独进行反射疗法对疲劳严重程度和3种次要症状结局的增加值。目标3.在第一个干预阶段对疲劳冥想练习没有反应的患者中，确定在第5-8周（第二个干预阶段）通过反射疗法与继续单独进行冥想练习对疲劳严重程度和3种次要症状结局的增加值。目标4。比较接受干预序列的两组和对照组之间疲劳严重程度和3种次要症状结局的改善。目标5。探索在第一个干预阶段观察到的二元特征与第二个干预阶段和第12周随访期间的最佳患者症状结局相关，以便确定未来干预阶段排序决策规则的定制变量。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最大限度地提高癌症治疗期间症状管理的益处来影响研究和实践。