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

项目总结/摘要 虽然同步放化疗（CRT）可以提高头颈部癌（HNC）的总生存率， 患者，它与使人衰弱的毒性有关（例如，粘膜炎、吞咽困难和疲劳），这可能导致 增加的保健利用（例如，急诊科（艾德）访视，饲管（FT）放置）期间 和治疗后。鉴于极高的治疗相关负担，HNC患者需要广泛的， 家人的关心和支持。病人的家庭照顾者是他们最重要和最受重视的 支持和照顾的来源;然而，照顾是身体和情感上的负担。事实上，家庭护理人员报告说， 心理痛苦、疲劳和睡眠障碍的发生率很高，这不仅可能危及他们自己的健康， 生活质量，以及他们能够为患者提供的护理质量。因此，基于证据， 迫切需要以患者和护理者结果为目标的二元支持性护理方案。到 解决关键的知识差距，并建立在我们的试点工作，我们提出了一个为期6周的二元疗效试验 瑜伽（DY）干预针对患者的健康利用和护理人员的QOL结果。拟议 研究将随机分配患者-护理者二人组，以二人瑜伽（DY）或常规护理（UC）作为对照 组为了增加可及性，干预措施将通过视频会议进行，随后我们的试点- 测试程序。将在基线时（随机化和开始治疗前）对患者和护理人员进行评估 CRT），然后在治疗结束时和1个月、3个月和6个月后再次进行。在治疗期间，我们将 每周评估患者和护理人员的症状。在3个月的随访评估中，我们将 并收集定性样本，以进一步了解参与者的经验。我们将整合来自 机构记录与自我报告的措施，以评估疗效，估计成本和评估成本- DY干预相对于UC对患者和护理人员的有效性。根据我们激动人心的试播集 研究结果，我们提出了一个中介模型假设，干预将影响病人和照顾者 通过改善症状负担、客观身体功能和关系幸福感， 使用定量和定性方法进行药物管理。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必要假设， 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 推进行为医学科学，并最终为弱势群体提供临床护理， 被忽视的人群 .

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. .