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

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:
10040568
负责人:
Kathrin Milbury
金额:
$44.21万
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
未结题
起止时间:
2020-09-15 至 2025-06-30
关键词:
AddressAdherenceAftercareBehavioral MedicineBehavioral SciencesBody Weight decreasedBreathing ExercisesCaregiversCaringCommunicationConsentCost AnalysisDataDeglutitionDeglutition DisordersDistressEducationEffectiveness of InterventionsEmergency department visitEmotionalEnteral FeedingExerciseFacilities and Administrative CostsFamilyFamily CaregiverFatigueFrightGuided imageryHead and Neck CancerHealthHybridsInterventionKnowledgeLeadLightLocationMalignant NeoplasmsMeasuresMediatingMediator of activation proteinMedical Care CostsMedication ManagementModelingModificationMucositisOpioidOutcomePainPain managementParticipantPatient Self-ReportPatientsPersonal SatisfactionPersonsPhysical ExercisePhysical FunctionPopulationProceduresQualitative MethodsQuality of CareQuality of lifeRandomizedRandomized Controlled TrialsRecordsRelaxation TechniquesReportingResearchSamplingSleep disturbancesSourceSpouse CaregiverSupportive careSymptomsTaxesTestingToxic effectTreatment ProtocolsUrsidae FamilyVideoconferencingWomanWorkYogabasecaregivingchemoradiationclinical carecomparison groupcontrol trialcopingcost effectivenesscost estimatecost-effectiveness evaluationdesignefficacy trialevidence baseexperiencefacial disfigurementfollow up assessmentfunctional declinehead and neck cancer patienthealth care service utilizationhigh riskimprovedinnovationintervention costloved onesmalignant breast neoplasmnutritionopioid use disorderpilot trialprimary outcomeproductivity lossprogramspsychological distresssecondary outcomesymptom managementsymptomatic improvementtreatment as usualtreatment durationtumorusual care arm

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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. .
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