Using a SMART Design to Optimize PTSD Symptom Management Strategies Among Cancer Survivors

使用 SMART 设计优化癌症幸存者的 PTSD 症状管理策略

• 批准号: 10063493
• 负责人: Allison Applebaum
• 金额: $ 67.17万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-12-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10063493
• 关键词: Address; Allogenic; Anxiety; Applications Grants; Area; Autologous; Cancer Center; Cancer Intervention; Cancer Survivor; Caring; Characteristics; Cognitive Therapy; Consent; Control Groups; Coupling; Data; Data Collection; Development; Diagnosis; Distress; Effectiveness; Eligibility Determination; Ensure; Goals; Health Care Costs; Healthcare; Impaired health; Income; Individual; Intensive Care; Intervention; Knowledge; Lead; Location; Low income; Malignant Neoplasms; Memory; Mental Health; Methods; Modeling; Numbness; Oncology; Outcome; Participant; Patients; Persons; Pilot Projects; Population; Post-Traumatic Stress Disorders; Process; Protocols documentation; Public Health; Quality of life; Race; Randomized; Recommendation; Regimen; Research; Research Personnel; Resources; Risk; Self Management; Sequential Multiple Assignment Randomized Trial; Sleep disturbances; Specific qualifier value; Stem cell transplant; Surveys; Survivors; Symptoms; Testing; Time; Transplantation; Travel; Treatment Protocols; Treatment-Related Cancer; United States Department of Veterans Affairs; Videoconferencing; Work; adaptive intervention; base; cancer diagnosis; cancer therapy; clinically significant; cost; cost effective; effective therapy; effectiveness evaluation; electronic data; experience; hematopoietic cell transplantation; high risk; improved; improved outcome; individual patient; individualized medicine; innovation; mHealth; mobile application; novel; patient response; personalized medicine; post intervention; prevent; programs; reduce symptoms; screening; sex; symptom management; tool; transplant survivor; transplantation therapy; treatment as usual; trial design; wasting

Project Summary/Abstract Cancer survivors often suffer from posttraumatic stress disorder (PTSD) symptoms as a result of their cancer diagnosis and treatment, which impair health outcomes such as quality of life (QOL). Although traditional office-based cognitive behavioral therapies (CBT) are effective, cancer survivors often lack access due to cost and distance barriers. At highest risk for persistent or worsening PTSD symptoms are low-income and/or nonwhite cancer survivors who received hematopoietic cell transplantation (HCT) as part of an aggressive cancer treatment. Mobile Health (mHealth) programs are increasingly used to facilitate access to CBT; some are self-guided and others require individualized, more intensive videoconferenced sessions with therapists. Hence, a continuum of mHealth CBT-based (mCBT) solutions with differing levels of intensity is available to support cancer survivors with PTSD symptoms. “Right-sizing” treatment ensures optimal benefit without wasting resources such as patient time and healthcare costs. This grant application aims to answer the question: What is the right intervention solution for this cancer survivor at risk for, or suffering from, PTSD symptoms? We propose to construct and refine an adaptive (individually-tailored) mHealth approach for managing symptoms of PTSD in cancer survivors who recently completed autologous or allogeneic HCT therapy, including those who are most at risk for poor outcomes and have the greatest opportunity to benefit. Our research team is comprised of national leaders in the area, including the investigators who have defined the problem as well as devised potential mCBT solutions. One of these solutions is Cancer Distress Coach, a mobile application developed in partnership with the National Center for PTSD, as an effective self-management tool for addressing symptoms. It will be used with more intensive mCBT therapies that require individualized sessions with therapists to address these study aims: 1) Evaluate the effectiveness of Cancer Distress Coach relative to a control in reducing PTSD symptoms among HCT cancer survivors; 2) Assess treatment regimens embedded in the trial design for PTSD symptom reduction; and 3) Estimate tailored treatment regimens for PTSD and related outcomes that generate hypotheses about if, and how treatment should be tailored. These aims address symptom management - one of ten National Cancer Moonshort Initiative recommendations – and the underserved have the greatest opportunity for benefit. Methods include using a Sequential Multiple Assignment Randomized Trial (SMART) to establish decision rules regarding when and in what way to intensify treatment for HCT cancer survivors (n=400) with Cancer Distress Coach and a more intensive mCBT. Electronic data collection surveys will be used and clickstream data captured to examine usage.

项目总结/摘要 癌症幸存者经常遭受创伤后应激障碍（PTSD）症状作为他们的癌症的结果 诊断和治疗，损害健康结果，如生活质量（QOL）。虽然传统 基于办公室的认知行为疗法（CBT）是有效的，癌症幸存者往往缺乏访问由于成本 距离障碍。PTSD症状持续或恶化的风险最高的是低收入和/或低收入人群。 接受造血细胞移植（HCT）作为积极治疗的一部分的非白人癌症幸存者 癌症治疗移动的健康（mHealth）计划越来越多地用于促进获得CBT;一些 有些人需要自我指导，有些人需要与治疗师进行个性化的、更密集的视频会议。 因此，一系列基于移动健康CBT（mCBT）的解决方案具有不同的强度水平，可用于 帮助有创伤后应激障碍症状的癌症幸存者“合适的尺寸”处理确保最佳效益， 浪费资源，例如患者时间和医疗保健成本。 这项拨款申请旨在回答这样一个问题：什么是这种癌症的正确干预解决方案 幸存者是否有患创伤后应激障碍的风险我们建议建立和完善一个自适应 （个性化）mHealth方法用于管理最近患有癌症幸存者的PTSD症状 已完成自体或同种异体HCT治疗，包括最有可能出现不良结果的患者， 有最大的机会受益。我们的研究团队由该地区的国家领导人组成， 包括定义问题并设计潜在mCBT解决方案的调查人员。之一 这些解决方案是癌症苦恼教练，一个移动的应用程序开发的伙伴关系与国家 创伤后应激障碍中心，作为解决症状的有效自我管理工具。它将与更多 强化mCBT治疗，需要与治疗师进行个性化治疗，以实现这些研究目标：1） 评估癌症痛苦教练相对于对照组在减少PTSD症状方面的有效性， HCT癌症幸存者; 2）评估试验设计中嵌入的PTSD症状治疗方案 减少;和3）估计PTSD的定制治疗方案和相关结果， 关于是否以及如何进行治疗的假设。这些目标解决症状管理-一 十个国家癌症月短倡议的建议-和服务不足有最大的 利益的机会。 方法包括使用序贯多重分配随机试验（SMART）来确定决策 关于何时以及以何种方式加强HCT癌症幸存者（n=400）癌症治疗的规则 痛苦教练和更密集的mCBT。将使用电子数据收集调查， 获取数据以检查使用情况。