Internet-Assisted Cognitive Behavior Intervention for Targeted Therapy Fatigue

互联网辅助认知行为干预靶向治疗疲劳

• 批准号: 8990831
• 负责人: HEATHER S.L. JIM
• 金额: $ 18.84万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-01 至 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8990831
• 关键词: Address; Adherence; Adopted; Adverse effects; Affect; Aftercare; American Society of Clinical Oncology; Antineoplastic Agents; Cancer Fatigue; Cancer Patient; Cancer Survivor; Caring; Chronic Disease; Chronic Myeloid Leukemia; Clinic; Clinical; Cognitive; Cognitive Therapy; Collaborations; Development; Disease; Drug Design; Evaluation; Evolution; Fatigue; Fostering; Foundations; Generations; Gleevec; Guidelines; Health; Imatinib; Internet; Intervention; Intervention Trial; Life; Maintenance; Malignant Neoplasms; Methods; Modeling; Molecular Target; Multi-Institutional Clinical Trial; Netherlands; Oral; Participant; Pathway interactions; Patients; Persons; Pharmaceutical Preparations; Physical activity; Provider; Publishing; Qualitative Research; Quality of life; Randomized Controlled Trials; Regimen; Research; Survival Rate; Symptoms; Tablet Computer; Technology; Time; Travel; Tyrosine Kinase Inhibitor; base; behavioral response; cancer therapy; chemotherapy; clinically significant; common symptom; experience; improved; medication compliance; model design; patient population; personalized approach; primary outcome; randomized trial; secondary outcome; targeted treatment; therapy design; treatment as usual; tumor growth; tumor progression

DESCRIPTION (provided by applicant): Targeted therapies are a new generation of drugs designed to interfere with molecular targets critical for tumor growth and progression. One of the first and most successful examples is the oral medication imatinib developed for chronic myelogenous leukemia (CML). Although imatinib and similar medications are much better tolerated than regimens they replaced, they still possess side effects that are bothersome to patients, interfere with quality of life, and contribute to problems with adherence. Since treatment typically continues on a daily basis for many years and may be life-long, effective management of side effects is critically important. Recent studies show that fatigue is the most common and bothersome symptom identified by CML patients being treated with oral targeted therapy. The proposed research represents the first systematic attempt to address the problem of targeted therapy-related fatigue (TTF). Toward this end, it builds on previous research showing that a form of cognitive behavior therapy (CBT) based on a precipitating-perpetuating model of symptom evolution is highly effective against fatigue in cancer patients with no clinical evidence of disease who have completed treatment (i.e., post-cancer fatigue or PCF). Accordingly, in collaboration with its developers, we will adapt CBT-PCF, an intervention based on the precipitating-perpetuating model for fatigued patients who completed treatment, to develop CBT-TTF, an intervention based on a revised precipitating-exacerbating model for fatigued patients on maintenance targeted therapy. Adopting the tailored modular approach of the original intervention, we will first conduct iterative qualitative research with fatigued CML patients and CML care providers to determine which CBT-PCF modules to retain and adapt and to identify potential new modules to develop based on the conceptual model. The adaptation also involves moving from clinic-based delivery to Internet-assisted delivery using video telephony and tablet computer technology (FaceTime using iPads) in order to minimize travel burden, maximize convenience, and foster greater dissemination potential. Once developed, CBT-TTF will be evaluated with fatigued CML patients on oral targeted therapy for feasibility, acceptability and potential efficacy relative to usual care only in a small-scale randomized controlled trial. The specific aims are to: 1) develop an Internet-assisted form of CBT for TTF (CBT-TTF) using as a foundation an empirically-supported form of CBT effective against post-treatment cancer-related fatigue; 2) evaluate CBT-TTF and related methods for feasibility and acceptability; 3) explore the efficacy of CBT-TTF in reducing fatigue (primary outcome); and 4) explore the efficacy of CBT-TTF in improving quality of life and oral medication adherence (secondary outcomes). Successful completion of this research will provide a strong foundation for a larger multi-center clinical trial expected to yield a highly effective and readily disseminale intervention that addresses a major treatment consequence in the growing population of patients for whom target therapies are transforming cancer from a life-threatening illness to a chronic illness.

描述（由申请人提供）：靶向治疗是新一代药物，旨在干扰对肿瘤生长和进展至关重要的分子靶点。最早也是最成功的例子之一是为慢性粒细胞白血病（CML）开发的口服药物伊马替尼。尽管伊马替尼和类似药物的耐受性比它们所取代的方案好得多，但它们仍然具有令患者烦恼的副作用，干扰生活质量，并导致依从性问题。由于治疗通常持续多年的日常基础上，可能是终身的，副作用的有效管理是至关重要的。最近的研究表明，疲劳是慢性粒细胞白血病患者接受口服靶向治疗时最常见和最令人烦恼的症状。这项研究代表了第一次系统性地尝试解决靶向治疗相关疲劳（TTF）问题。为此，它建立在以前的研究基础上，这些研究表明，基于症状演变的沉淀-持久模型的认知行为疗法（CBT）形式对没有疾病临床证据的癌症患者的疲劳非常有效，这些患者已经完成治疗（即，癌症后疲劳或PCF）。因此，我们将与其开发人员合作，调整CBT-PCF，一种基于完成治疗的疲劳患者的加速-永久模型的干预措施，以开发CBT-TTF，一种基于维持靶向治疗的疲劳患者的修订加速-恶化模型的干预措施。采用原始干预的定制模块化方法，我们将首先对疲劳的CML患者和CML护理提供者进行迭代定性研究，以确定保留和调整哪些CBT-PCF模块，并根据概念模型确定潜在的新模块。调整还涉及从诊所提供服务转向使用视频电话和平板电脑技术（使用iPad的FaceTime）的互联网辅助提供服务，以最大限度地减少旅行负担，最大限度地提供便利，并促进更大的传播潜力。一旦开发出来，CBT-TTF将在一项小规模随机对照试验中对接受口服靶向治疗的疲劳CML患者进行可行性、可接受性和相对于常规治疗的潜在疗效评估。具体目标是：1）以一种有效对抗癌症治疗后相关疲劳的计算机支持的CBT形式为基础，开发一种用于TTF的互联网辅助CBT形式（CBT-TTF）; 2）评估CBT-TTF和相关方法的可行性和可接受性; 3）探索CBT-TTF在减轻疲劳方面的功效（主要结局）;和4）探讨CBT-TTF在改善生活质量和口服药物依从性方面的疗效（次要结局）。这项研究的成功完成将为一项更大规模的多中心临床试验提供坚实的基础，该试验有望产生一种高效且易于传播的干预措施，解决日益增长的患者人群中的主要治疗后果，这些患者的靶向治疗正在将癌症从危及生命的疾病转变为慢性疾病。

项目成果

Adapting an Evidence-Based Intervention to Address Targeted Therapy-Related Fatigue in Chronic Myeloid Leukemia Patients.

采用循证干预措施来解决慢性粒细胞白血病患者与靶向治疗相关的疲劳。

• DOI: 10.1097/ncc.0000000000000446
• 发表时间: 2018
• 期刊: Cancer nursing
• 影响因子: 2.6
• 作者: Poort,Hanneke;Meade,CathyD;Knoop,Hans;Gielissen,MariekeFM;Pinilla-Ibarz,Javier;Jacobsen,PaulB
• 通讯作者: Jacobsen,PaulB