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: 10614618
• 负责人: Terry A Badger
• 金额: $ 63.73万
• 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/10614618
• 关键词: Address; Affect; Anxiety; Cancer Survivor; Characteristics; Cognitive; Common Terminology Criteria for Adverse Events; Communication; 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; Malignant Neoplasms; Mediating; Mental Depression; Monitor; Oral; Organ; Pain; Participant; Patient Outcomes Assessments; Patient Selection; Population; Printing; 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; Work; active control; active control group; adaptive intervention; cancer therapy; cancer type; design; end of life; 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; treatment guidelines; 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.

免疫检查点抑制剂（ICI）单独或与其他癌症治疗联合使用， 随着ICI治疗期间常见的免疫相关不良事件（irAE）（90%）而急剧增加。最 irAE是症状性和症状自我管理，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 中断和不定期的保健服务。使用序贯多分配随机试验 （SMART）设计，我们最初将随机选择286名不同的幸存者（30%西班牙裔），他们在12周内 开始ICI，并且心理困扰也上升到自动电话症状 管理（ATSM）或主动控制条件。ATSM包括每周电话症状 通过自动语音应答技术使用PRO-CTCAE项目进行监测。参与者 参考了一本印刷的手册，其中有关于症状的信息，基于证据的自我管理策略， 以及何时向HCP报告症状。ATSM自动向HCP发送每周症状摘要。 活性对照幸存者将仅接受自动症状监测，并将报告发送给HCP。幸存者 在第2 - 8周期间心理困扰连续2周仍然升高的ATSM中（非 应答者）将第二次随机分配，以添加TIPC持续8周或继续单独使用ATSM。我们 假设增加TIPC将提高症状自我管理自我效能，包括沟通 HCP和增加社会支持导致心理困扰指数降低，其他PRO-CTCAE 症状、临床医生记录的irAES（主要结局）、计划外卫生服务使用和ICI 治疗中断（次要结局）。总干预时间为16周，所有幸存者将 在基线和干预后第17周进行访谈，并提取电子健康记录数据， 参与期。具体目标：目标1。确定第1 - 17周的主要和次要结局 在第一次随机化创建的组中较低（较好）：从以下开始的适应性干预 与活性对照组相比，ATSM与基于需求的TIPC添加。目标二。在那些没有回应的人中， 在第2 - 8周期间对进入第二次随机化的心理困扰进行ATSM，确定：a）如果 TIPC + ATSM组第8 - 17周的主要和次要结局低于（优于）单独ATSM组; B） ATSM中增加TIPC对主要和次要结局的影响程度由以下因素介导： 增加社会支持、症状管理和与HCP沟通的自我效能。目标3。 探索幸存者、癌症和癌症治疗的哪些基线特征与 三种支持性治疗方案产生的最佳主要和次要结局：1）症状监测 仅向HCP自动报告（活性对照）; 2）ATSM单独给药16周;或3）添加8周 如果在第2 - 8周期间对心理困扰没有反应，则TIPC为ATSM。