Improving Health Utilization and Quality of Life in Head and Neck Cancer Patients Undergoing Chemoradiation and their Family Caregivers

改善接受放化疗的头颈癌患者及其家庭护理人员的健康利用和生活质量

• 批准号: 10263936
• 负责人: Kathrin Milbury
• 金额: $ 44.21万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10263936
• 关键词: Address; Adherence; Aftercare; Behavioral Medicine; Behavioral Sciences; Body Weight decreased; Breathing Exercises; Caregivers; Caring; Communication; Consent; Cost Analysis; Data; Deglutition; Deglutition Disorders; Distress; Education; Effectiveness of Interventions; Emergency department visit; Emotional; Enteral Feeding; Exercise; Facilities and Administrative Costs; Family; Family Caregiver; Fatigue; Fright; Guided imagery; Head and Neck Cancer; Health; Hybrids; Intervention; Knowledge; Lead; Light; Location; Malignant Neoplasms; Measures; Mediating; Mediator of activation protein; Medical Care Costs; Medication Management; Modeling; Modification; Mucositis; Opioid; Outcome; Pain; Pain management; Participant; Patient Self-Report; Patients; Personal Satisfaction; Persons; Physical Exercise; Physical Function; Population; Procedures; Qualitative Methods; Quality of Care; Quality of life; Randomized; Randomized Controlled Trials; Records; Relaxation Techniques; Reporting; Research; Sampling; Sleep disturbances; Source; Spouse Caregiver; Supportive care; Symptoms; Taxes; Testing; Toxic effect; Treatment Protocols; Ursidae Family; Videoconferencing; Woman; Work; Yoga; acceptability and feasibility; base; caregiving; chemoradiation; clinical care; comparison group; control trial; coping; cost effectiveness; cost estimate; cost-effectiveness evaluation; design; efficacy evaluation; efficacy trial; evidence base; experience; facial disfigurement; follow up assessment; functional decline; head and neck cancer patient; health care service utilization; high risk; improved; innovation; intervention cost; loved ones; malignant breast neoplasm; nutrition; opioid use disorder; pilot trial; primary outcome; productivity loss; programs; psychological distress; secondary outcome; symptom management; symptomatic improvement; treatment as usual; treatment duration; tumor; usual care arm

PROJECT SUMMARY/ABSTRACT Although concurrent chemoradiation (CRT) improves the overall survival for head and neck cancer (HNC) patients, it is associated with debilitating toxicities (e.g., mucositis, dysphagia, and fatigue), which may lead to increased healthcare utilization (e.g., emergency department (ED) visits, feeding tube (FT) placements) during and after treatment. In light of the extremely high treatment-related burden, HNC patients need extensive and persistent care and support from their families. Patients' family caregivers are their most important and valued source of support and care; yet, caregiving is physically and emotionally taxing. In fact, family caregivers report high rates of psychological distress, fatigue, and sleep disturbances, which may not only compromise their own quality of life but also the quality of care they are able to provide to the patient. Therefore, evidence-based, dyadic supportive care programs targeting both patient and caregiver outcomes are urgently needed. To address critical knowledge gaps and build upon our pilot work, we propose an efficacy trial of a 6-week dyadic yoga (DY) intervention targeting patient health utilization and caregiver QOL outcomes. The proposed research will randomly assign patient-caregiver dyads to either a dyadic yoga (DY) or usual care (UC) control group. To increase accessibility, the intervention will be delivered via video-conferencing following our pilot- tested procedures. Patients and caregivers will be assessed at baseline (prior to randomization and starting CRT) and then again, at the end of treatment and 1, 3, and 6 months later. During the treatment period, we will assess patients and caregivers' symptoms on a weekly basis. At the 3-month follow-up assessment, we will also collect qualitative samples to further understand participants' experiences. We will integrate data from institutional records with self-report measures to evaluate efficacy, estimate costs and assess the cost- effectiveness of the DY intervention relative to UC for both patients and caregivers. Based on our exciting pilot findings, we propose a mediational model hypothesizing that the intervention will impact patient and caregiver outcomes via improved symptom burden, objective physical function, and relationship well-being and reduced pharmacological management using quantitative and qualitative methods. Thus, this innovative and scientifically rigorous design will address imperative hypotheses that are highly relevant to the clinical care of a vulnerable patient-caregiver population. The knowledge gained from this randomized controlled trial will advance the science of behavioral medicine, and, ultimately, inform the clinical care of a vulnerable and understudied population. .

项目摘要/摘要 虽然同期放化疗(CRT)提高了头颈部癌(HNC)的总体存活率 对于患者，它与衰弱的毒性(如粘膜炎、吞咽困难和疲劳)有关，这可能导致 提高医疗保健利用率(例如，急诊科(ED)就诊、放置喂养管(FT)) 并在治疗后。鉴于极高的治疗相关负担，HNC患者需要广泛和 家人坚持不懈的关怀和支持。患者的家庭照顾者是他们最重要和最重视的 支持和关爱的源泉；然而，照料是身体和情感上的累赘。事实上，家庭照顾者报告说 高比例的心理困扰、疲劳和睡眠障碍，这不仅可能危及他们自己的健康 不仅是生活质量，还包括他们能够为患者提供的护理质量。因此，以证据为基础， 迫切需要针对患者和照顾者结果的并行式支持性护理计划。至 解决关键的知识差距，并在我们试点工作的基础上，我们建议进行为期6周的二元组疗效试验 针对患者健康利用和照顾者生活质量结果的瑜伽(DY)干预。建议数 研究将患者和照顾者随机分配到二元瑜伽(DY)或日常护理(UC)对照组 一群人。为了增加可及性，干预将在我们的试点之后通过视频会议进行- 经过测试的程序。患者和照顾者将在基线上(在随机和开始之前)进行评估 CRT)，然后在治疗结束以及1、3和6个月后再次治疗。在治疗期间，我们将 每周评估患者和照顾者的症状。在为期3个月的跟踪评估中，我们将 还要收集定性样本，以进一步了解参与者的体验。我们将集成来自 具有自我报告措施的机构记录，以评估疗效、估计成本和评估成本- DY干预相对于UC对患者和照顾者的有效性。基于我们激动人心的飞行员 结果，我们提出了一个中介模型，假设干预将影响患者和照顾者 通过改善症状负担、客观身体功能和人际关系幸福感而减少的结果 药理管理采用定量和定性相结合的方法。因此，这一创新和 科学严谨的设计将解决与临床护理高度相关的命令性假设 脆弱的病人照顾者群体。从这项随机对照试验中获得的知识将 推进行为医学的科学，并最终为易受伤害和 未被充分研究的人群。 。