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

改善非正式护理人员和癌症幸存者的心理困扰、症状管理和医疗保健使用

• 批准号: 10174863
• 负责人: Terry A Badger
• 金额: $ 61.03万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-06 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10174863
• 关键词: Anxiety; Cancer Survivor; Caregiver Burden; Caregivers; Caring; Characteristics; Clinic; Clinical; Counseling; Data; Diagnosis; Distress; Dose; Emergency department visit; Enrollment; Evidence based intervention; Exhibits; Family member; Friends; Future; Health; Healthcare; Heterogeneity; Hospitalization; Individual; Intervention; Logic; Mediator of activation protein; Mental Depression; Outcome; Pain; Participant; Procedures; Randomized; Randomized Controlled Trials; Reporting; Research; Sampling; Self Efficacy; Sequential Multiple Assignment Randomized Trial; Severities; Sleeplessness; Social support; Solid Neoplasm; Sum; Survivors; Symptoms; Telephone; Testing; Time; Treatment Efficacy; United States; Work; base; cancer therapy; chemotherapy; common symptom; design; evidence base; follow-up; health care service utilization; implementation study; improved; informal caregiver; member; personalized approach; post intervention; preference; primary caregiver; primary outcome; psychological distress; psychosocial; recruit; response; secondary outcome; symptom management; symptom self management; symptomatic improvement; targeted treatment; trial design; urgent care

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.

非正式护理人员（通常是家庭成员或朋友）提供了 5.7 所需护理的一半以上 美国有数百万癌症幸存者，往往对健康造成负面影响。至少 30% 幸存者及其照顾者报告心理困扰（抑郁和焦虑），这种痛苦可能 干扰最佳症状管理。这项研究将为幸存者护理人员提供支持 管理幸存者癌症和治疗相关症状的二元关系以及二元关系的 心理困扰。设计：我们将使用序贯多重分配随机试验（SMART） 设计，一种较新的自适应设计。 SMART 超越了传统的 RCT，采用了一种精确的方法来 为正确的幸存者-护理人员二人组确定正确剂量和正确顺序的正确治疗方法。我们 将使用两种基于证据的干预措施：症状管理工具包（SMT）和电话人际交往 咨询（TIP-C）。虽然我们已经确定了这些干预措施的总体功效，但个体差异 在回应中。当干预措施最初不起作用时，临床逻辑是要么延长时间，要么 规定不同的干预措施。然而，此类替代方案很少经过测试，也很少有证据支持。然而，他们 将在这项研究中。示例：我们将招募 298 名抑郁或焦虑程度较高的幸存者，他们 正在接受实体瘤化疗或靶向治疗的人及其 298 名护理人员。程序：二元组 最初将被随机分配至单独 SMT 或 TIP-C +SMT。如果幸存者的抑郁或焦虑加剧 在第 4 周之前未单独对 SMT 作出反应，将重新随机分组继续进行 SMT，以给予更多时间或 至 TIP-C+SMT。将在基线、第 13 周（干预后）和第 17 周（后续）收集结果数据。 第 1-12 周期间的评估将记录症状的变化、干预措施的接收、实施和 保真度。具体目标： 1) 确定 TIP-C+SMT 中的二元组与仅 SMT 组相比是否创建 第一次随机分组将：a) 降低抑郁、焦虑和 13 种其他症状的总严重程度 第 1-12、13 和 17 周（主要结果）； b) 医疗保健服务的使用率较低（住院、紧急治疗） 17 周期间的护理或急诊科就诊（次要结果）； c) 更高的自我效能感， 第 13 周和第 17 周期间的社会支持和较低的照顾者负担（潜在的调解因素）。 2) 在非 4 周后仅对 SMT 做出反应的人，确定分配给 TIP-C+SMT 的二人组是否与分配给 TIP-C+SMT 的人相比 由第二次随机分组创建的单独 SMT 组将具有更好的主要和次要结果，并且 第 5-12、13 和 17 周的潜在调解者。 3) 测试幸存者和照顾者的相互依赖性 主要和次要结果。 4) 确定二元组的哪些特征与 第 1-4 周对单独 SMT 的反应以及第 1-12、13 周和 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并减少幸存者与照顾者二人组的痛苦。

项目成果

Social determinants of health, psychological distress, and caregiver burden among informal cancer caregivers of cancer survivors during treatment.

癌症幸存者在治疗期间的非正式癌症护理人员的健康、心理困扰和护理负担的社会决定因素。

• DOI: 10.1080/07347332.2023.2248486
• 发表时间: 2023
• 期刊: Journal of psychosocial oncology
• 影响因子: 2.1
• 作者: Badger,Terry;Segrin,Chris;Crane,Tracy;Morrill,Kristin;Sikorskii,Alla
• 通讯作者: Sikorskii,Alla

Use of scheduled and unscheduled health services by cancer survivors and their caregivers.

• DOI: 10.1007/s00520-022-07157-5
• 发表时间: 2022-09
• 期刊: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

Social Determinants of Health and Symptom Burden During Cancer Treatment.

癌症治疗期间健康和症状负担的社会决定因素。

• DOI: 10.1097/nnr.0000000000000636
• 发表时间: 2023
• 期刊: Nursing research
• 影响因子: 2.5
• 作者: Badger,TerryA;Segrin,Chris;Crane,TracyE;Chalasani,Pavani;Arslan,Waqas;Hadeed,Mary;Sikorskii,Alla
• 通讯作者: Sikorskii,Alla