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 尽管并发化学放疗（CRT）改善了头颈癌的总体存活率（HNC） 患者，它与衰弱的毒性（例如粘膜炎，吞咽困难和疲劳）有关，这可能导致 增加医疗保健利用率（例如，急诊科（ED）访问，进食管（FT）安置） 并在治疗后。鉴于与治疗相关的负担非常高，HNC患者需要广泛 持续的照顾和家人的支持。患者的家庭护理人员是他们最重要和有价值的 支持和护理的来源；然而，护理在身体和情感上征税。实际上，家庭护理人员报告 高度的心理困扰，疲劳和睡眠障碍，这不仅可能损害自己的 生活质量以及他们能够为患者提供的护理质量。因此，基于证据， 迫切需要针对患者和护理人员结果的二元支持护理计划。到 解决关键知识差距并建立在我们的飞行员工作的基础上，我们提出了为期6周的二元组的功效试验 针对患者健康利用和护理人员QOL结果的瑜伽（DY）干预措施。提议 研究将随机分配患者保养的二元组为二元瑜伽（DY）或通常的护理（UC）控制 团体。为了提高可访问性，干预将通过我们的飞行员进行视频会议进行 - 测试程序。将在基线时评估患者和护理人员（在随机和开始之前 CRT），然后在治疗结束时，在1、3和6个月后。在治疗期间，我们将 每周评估患者和看护人的症状。在3个月的随访评估中，我们将 还收集定性样本，以进一步了解参与者的经验。我们将整合来自 通过自我报告措施评估疗效，估计成本并评估成本的机构记录 患者和看护人相对于UC的DY干预措施的有效性。根据我们激动人心的飞行员 调查结果，我们提出了一个中介模型，假设干预会影响患者和护理人员 通过改善症状负担，客观的身体机能和关系健康和减少的结局 使用定量和定性方法的药理管理。因此，这种创新和 科学严格的设计将解决与临床护理高度相关的命令假设 脆弱的患者照顾者人数。从这个随机对照试验中获得的知识将 推进行为医学的科学，并最终告知脆弱和临床护理 研究的人口。 。