Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors

适应性症状自我管理可减少免疫检查点抑制剂幸存者的心理困扰并改善症状管理

• 批准号: 10459116
• 负责人: Terry A Badger
• 金额: $ 65.01万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10459116
• 关键词: Address; Affect; Anxiety; Cancer Survivor; Characteristics; Cognitive; Common Terminology Criteria for Adverse Events; Communication; Control Groups; Counseling; Data; Diagnosis; Dose; Electronic Health Record; Electronic Mail; Emergency department visit; Emotional; Exanthema; Fatigue; Guidelines; Health Insurance Portability and Accountability Act; Health Personnel; Health Services; Hematologic Neoplasms; Hispanic; Hospitalization; Immune checkpoint inhibitor; Individual; Interruption; Intervention; Interview; Lead; Link; Mediating; Mental Depression; Monitor; Oral; Organ; Pain; Participant; Patient Outcomes Assessments; Population; Randomized; Reporting; Resources; Science; Self Efficacy; Self Management; Sentinel; Sequential Multiple Assignment Randomized Trial; Severities; Social support; Solid; Steroids; Supportive care; Survivors; Symptoms; Systemic Therapy; Technology; Telephone; Testing; Time; Treatment-Related Cancer; Voice; active control; adaptive intervention; base; cancer therapy; cancer type; design; evidence base; experience; handbook; health service use; immune-related adverse events; improved; indexing; post intervention; prevent; primary outcome; psychological distress; response; secondary outcome; sleep difficulty; success; symptom management; symptom self management; symptomatic improvement; trial design

The use of immune checkpoint inhibitors (ICIs), alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events (irAEs) common (90%) during ICI treatment. Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to HCPs may reduce irAE severity by early recognition and management, resulting in fewer treatment interruptions and unscheduled health services. Using a sequential multiple assignment randomized trial (SMART) design, we will initially randomize 286 diverse survivors (30% Hispanic) who are within 12 weeks of starting ICIs and who also have elevated psychological distress to an Automated Telephone Symptom Management (ATSM) or to an active control condition. ATSM consists of weekly telephone symptom monitoring using the PRO-CTCAE items by an automated voice response technology. Participants are referred to a printed Handbook with information about symptoms, evidence-based self-management strategies, and when to report symptoms to HCPs. ATSM automatically sends a weekly symptom summary to HCPs. Active control survivors will receive automated symptom monitoring only with reports sent to HCPs. Survivors in ATSM whose psychological distress is still elevated for 2 consecutive weeks during weeks 2-8 (non- responders) will be randomized for the second time to add TIPC for 8 weeks or continue with ATSM alone. We hypothesize adding TIPC will improve self-efficacy for symptom self-management, including communication with HCPs and increase social support resulting in lower indices of psychological distress, other PRO-CTCAE symptoms, clinician-documented irAES (primary outcomes), and unscheduled health services use and ICI treatment interruptions (secondary outcomes). With total intervention time of 16 weeks, all survivors will be interviewed at baseline and week 17 post-intervention, and electronic health record data will be extracted for the participation period. Specific aims: Aim 1. Determine if primary and secondary outcomes over weeks 1-17 are lower (better) in the group created by the first randomization: the adaptive intervention that begins with ATSM with the need-based addition of TIPC vs. active control group. Aim 2. Among those not responding to ATSM on psychological distress during weeks 2-8 who enter the second randomization, determine: a) if primary and secondary outcomes over weeks 8-17 are lower (better) in TIPC+ATSM vs. ATSM alone group; b) the extent to which the effects of adding TIPC to ATSM on primary and secondary outcomes are mediated by increased social support, self-efficacy for symptom management and for communication with HCP. Aim 3. Explore which baseline characteristics of the survivor, cancer, and cancer treatment are associated with optimal primary and secondary outcomes resulting from three supportive care options: 1) symptom monitoring only with automated reports to HCPs (active control); 2) ATSM alone for 16 weeks; or 3) addition of 8 weeks of TIPC to ATSM if no response on psychological distress during weeks 2-8.

使用免疫检查点抑制剂（ICI），单独或与其他癌症治疗结合使用是 在ICI治疗期间，与免疫相关的不良事件（IRAE）共同（90％）急剧增加。最多 伊拉斯是症状和症状自我管理，及时报告中度或重度症状 HCP可以通过早期识别和管理降低IRAE的严重程度，从而减少治疗 中断和计划外的卫生服务。使用顺序多重分配随机试验 （智能）设计，我们最初将在12周内的12周内随机化286个不同的幸存者（30％西班牙裔） 开始ICIS，并且对自动电话症状的心理困扰也更高 管理（ATSM）或活动控制条件。 ATSM包括每周电话症状 通过自动语音响应技术使用Pro-CTCAE项目进行监视。参与者是 介绍了一本印刷手册，其中包含有关症状，基于证据的自我管理策略的信息， 以及何时向HCP报告症状。 ATSM自动将每周症状摘要发送给HCP。 主动控制幸存者将仅通过发送给HCP的报告接受自动症状监测。幸存者 在ATSM中，在2-8周，心理困扰仍连续2周升高（非 - 响应者）将第二次随机分组以添加TIPC 8周，或仅继续进行ATSM。我们 假设添加提示将提高症状自我管理的自我效能，包括沟通 随着HCP并增加社会支持，导致心理困扰的指标较低，其他亲CTCAE 症状，临床医生记录的伊拉斯（主要结果）以及未定规划的卫生服务使用和ICI 治疗中断（次要结果）。由于总干预时间为16周，所有幸存者将 干预后的基线和第17周接受了采访，并将提取电子健康记录数据 参与期。具体目的：目标1。确定在第1-17周内的初级和次要结果是否出现 在第一个随机化创建的组中较低（更好）：从 ATSM与TIPC与活动对照组的基于需求的添加。目标2。在没有回应的人中 进入第二个随机分组的第2-8周的心理困扰的ATSM，确定：a）如果 在TIPC+ATSM与ATSM组中，第8-17周的初级和次要结果较低（更好）； b） 将TIPC添加到ATSM对主要结果和次级结果的影响的程度是由 增加社会支持，症状管理的自我效能以及与HCP的沟通。目标3。 探索幸存者，癌症和癌症治疗的哪些基线特征与 由三种支持性护理选项产生的最佳初级和次要结果：1）症状监测 仅在HCPS（主动控制）的自动报告中； 2）仅ATSM持续16周；或3）增加8周 如果在第2-8周没有对心理困扰的反应，则提示ATSM。