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）：靶向疗法是一种新一代药物，旨在干扰对肿瘤生长和进展至关重要的分子靶标。第一个也是最成功的例子之一是为慢性粒细胞性白血病（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要比替换的方案要好得多，但它们仍然具有使患者造成麻烦的副作用，干扰了生活质量，并导致依从性问题。由于治疗通常每天持续多年，并且可能是终生的，因此对副作用的有效管理至关重要。最近的研究表明，疲劳是接受口服靶向疗法治疗的CML患者发现的最常见和麻烦的症状。拟议的研究是解决针对治疗相关疲劳（TTF）问题的首次系统尝试。为此，它建立在先前的研究基础上，表明一种基于症状进化的降水 - 过期模型的一种认知行为疗法（CBT）形式非常有效地抵抗未完成治疗的临床疾病证据（即，后癌后疲劳或PCF）。因此，与其开发人员合作，我们将根据CBT-PCF进行调整，该干预措施是基于疲劳患者的沉淀 - 过期模型，以开发CBT-TTF，这是一种基于经修订的降水性降压模型的干预措施。采用原始干预的量身定制的模块化方法，我们将首先与疲劳的CML患者和CML护理提供商进行迭代定性研究，以确定哪些CBT-PCF模块保留和适应，并根据概念模型确定潜在的新模块以开发以开发的新模块。适应还涉及从基于诊所的交付到使用视频电话和平板电脑技术（使用iPad的FaceTime）的互联网辅助交付，以最大程度地减轻旅行负担，最大化便利性并促进更大的传播潜力。一旦开发，CBT-TTF将与疲劳的CML患者进行口服靶向治疗，以实现可行性，可接受性和潜在疗效，仅在小型随机对照试验中，相对于常规护理。具体目的是：1）使用作为基础，以实证支持的CBT形式为TTF（CBT-TTF）开发一种互联网辅助形式的CBT（CBT-TTF），可有效地针对治疗后癌症相关的疲劳； 2）评估CBT-TTF和相关方法的可行性和可接受性； 3）探索CBT-TTF在减少疲劳方面的功效（主要结果）； 4）探索CBT-TTF在改善生活质量和口服药物依从性（次要结果）方面的功效。这项研究的成功完成将为更大的多中心临床试验提供巨大的基础，预计将产生高效且容易分散的干预措施，以解决对目标疗法不断变化的患者人群的重大治疗后果，这些患者正在将癌症从威胁生命的疾病转变为慢性病。

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