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: 10684253
• 负责人: Kathrin Milbury
• 金额: $ 43.19万
• 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 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684253
• 关键词: Address; Adherence; Aftercare; Behavioral Medicine; Behavioral Sciences; Body Weight decreased; Breathing Exercises; Caregivers; Caring; Communication; Consent; Cost Analysis; Deglutition; Deglutition Disorders; Distress; Education; Effectiveness of Interventions; Emergency department visit; Emotional; Enteral Feeding; Exclusion; Exercise; Facilities and Administrative Costs; Family; Family Caregiver; Fatigue; Fright; Guided imagery; Head and Neck Cancer; Health; Hybrids; Institution; Intervention; Knowledge; Light; Location; Malignant Neoplasms; Measures; Mediating; Mediator; Medical Care Costs; Medication Management; Modeling; Modification; Mucositis; Opioid; Outcome; Pain; Pain management; Participant; Patient Care; 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; Toxic effect; Treatment Protocols; Videoconferencing; Woman; Work; Yoga; acceptability and feasibility; caregiving; chemoradiation; clinical care; comparison group; coping; cost effectiveness; cost estimate; cost-effectiveness evaluation; data integration; 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 test; 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. .

项目概要/摘要 尽管同步放化疗 (CRT) 可以提高头颈癌 (HNC) 的总体生存率 对于患者来说，它与使人衰弱的毒性（例如粘膜炎、吞咽困难和疲劳）有关，这可能会导致 期间增加医疗保健利用率（例如急诊科 (ED) 就诊、饲管 (FT) 放置） 以及治疗后。鉴于极高的治疗相关负担，HNC 患者需要广泛和 家人的持续关怀和支持。患者的家人照顾者是他们最重要和最有价值的 支持和关怀的来源；然而，护理在身体和情感上都是一种负担。事实上，家庭护理人员报告 心理困扰、疲劳和睡眠障碍的发生率很高，这不仅会损害他们自己的健康 生活质量以及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护理人员结果的二元支持性护理计划。到 为了解决关键的知识差距并以我们的试点工作为基础，我们提出了为期 6 周的双元有效性试验 瑜伽（DY）干预针对患者健康利用和护理人员生活质量结果。拟议的 研究将随机将患者-护理人员二人组分配给二元瑜伽（DY）或常规护理（UC）对照 团体。为了提高可及性，干预措施将在我们的试点之后通过视频会议进行 经过测试的程序。患者和护理人员将在基线时接受评估（在随机化和开始之前） CRT），然后在治疗结束时以及 1、3 和 6 个月后再次进行。在治疗期间，我们会 每周评估患者和护理人员的症状。在3个月的跟踪评估中，我们将 还收集定性样本以进一步了解参与者的经历。我们将整合来自 具有自我报告措施的机构记录，用于评估功效、估算成本和评估成本 DY 干预相对于 UC 对患者和护理人员的有效性。基于我们激动人心的试点 根据研究结果，我们提出了一个中介模型，假设干预措施将影响患者和护理人员 通过改善症状负担、客观身体机能和关系健康来改善结果，并减少 使用定量和定性方法进行药理学管理。因此，这种创新和 科学严谨的设计将解决与临床护理高度相关的必要假设 弱势患者护理人员群体。从这项随机对照试验中获得的知识将 推进行为医学科学，并最终为弱势群体和弱势群体的临床护理提供信息 未被充分研究的人群。 。