Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

建立口腔癌患者的淋巴水肿和纤维化措施

基本信息

批准号：
9223690
负责人：
Jie Deng
金额：
$ 60.12万
依托单位：
VANDERBILT UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-03-01 至 2018-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9223690
关键词：
Activities of Daily Living Acute Address Anatomy Area Assessment tool Automobile Driving Body Image Cancer Patient Cancer Survivor Characteristics Clinical Clinical Research Common Terminology Criteria for Adverse Events Data Collection Deglutition Dental Development Distress Emotional Face Family Fibrosis Future Goals Head and neck structure Health Health Policy Healthcare Systems Home environment Imaging Techniques Impairment Incidence Individual Infiltration Investigation Late Effects Longitudinal Studies Lymphatic System Lymphedema Mastication Measurement Measures Modality Monitor National Institute of Dental and Craniofacial Research Operative Surgical Procedures Oral Oral cavity Outcome Outcome Measure Participant Patient Outcomes Assessments Patients Physiological Pilot Projects Population Psychometrics Publications Quality of life Radiation Recovery Recruitment Activity Reporting Research Personnel Respiratory distress Severities Signal Transduction Site Soft Tissue Neoplasms Strategic Planning Structure Surveys Swelling Symptoms Time Tissues Tongue Treatment Efficacy Ultrasonography Validation Validity and Reliability Work X-Ray Computed Tomography associated symptom cancer therapy care delivery collaborative environment craniofacial design elastography functional disability head and neck cancer patient high risk imaging modality improved improved outcome malignant mouth neoplasm malignant oropharynx neoplasm novel strategies psychologic public health relevance research study screening social soft tissue standard measure tool treatment effect

项目摘要

DESCRIPTION (provided by applicant): Aggressive multi-modality therapy for oral cavity and oropharyngeal cancer have improved local control and survival; however, improved outcomes are often at the expense of significant acute and late treatment effects. A common but under-identified late effect in this population is lymphedema and fibrosis (LEF). LEF may involve both external (e.g., face) and internal structures (e.g., tongue). LEF severity is associated with substantial symptom burden, functional impairments, and decreased quality of life. However, measurement of LEF in oral cavity and oropharyngeal cancer patients is challenging. Currently, no psychometrically validated patient- reported outcome measure is available to evaluate LEF in this population. Our recent publication indicated that available clinician-reported outcome measures for external head and neck LEF are problematic. The Patterson Scale has been used in few studies to evaluate internal swelling as no current standard measure of internal LEF has been developed. However, the Patterson Scale fails to capture important anatomical sites (e.g., oral tongue) that may develop internal LEF. In addition, commonly used imaging techniques (CT scan and ultrasonography) may provide objective signals to visualize LEF-related soft tissues changes in the oral and craniofacial structures. However, these frequently used imaging modalities have not been systematically evaluated for possible use in assessing LEF in this population. The National Institute of Dental and Craniofacial Research (NIDCR) Strategic Plan 2009-2013, Objective III-1, states: "Conduct well-designed, definitive clinical research studies that improve oral, dental, and craniofacial health and support more effective care delivery and health policies." The NIDCR emphasizes the need to "develop new approaches to meet this objective." In keeping with the NIDCR Strategic Plan, we developed a patient-reported outcome measure and a clinician- reported outcome measure for head and neck LEF in our pilot studies. The primary goal of this study is to establish a valid, clinically useful measurement battery for head and neck LEF. Specific Aims are to: 1) determine the reliability and validity of the patient-reported outcome measure (LSIDS-H&N) for assessing LEF- related symptoms; 2) determine the reliability and validity of the clinician-reported outcome measures (HN- LEF Grading Criteria and Modified Patterson Scale) for assessing external and internal LEF; and 3) determine the reliability and validity of imaging techniques (CT scan and ultrasound with grayscale and strain elastography) in identifying site-specific LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival. We plan to recruit 120 participants via a four-year, longitudinal study. Data collection will take place at pre-treatment, end of treatment and every 3-months up to 12-months post cancer treatment. If our aims are achieved, clinicians will be able to use the validated measures to: 1) identify LEF associated symptoms; 2) refer appropriate patients for LEF treatment; and 3) monitor the results of therapy. Researchers will be provided with much needed tools for future investigations in this area.

描述（由申请人提供）：口腔癌和口咽癌的积极多模式治疗改善了局部控制和生存；然而，改善的结果往往是以显着的急性和晚期治疗效果为代价的，这是一种常见但尚未明确的晚期效果。在该人群中，淋巴水肿和纤维化（LEF）可能涉及外部（例如面部）和内部结构（例如舌头），LEF 的严重程度与严重的症状负担、功能相关。然而，口腔癌和口咽癌患者的 LEF 测量具有挑战性，目前没有经过心理测量验证的患者报告的结果测量可用于评估该人群的 LEF。报道的外部头部和颈部 LEF 的结果测量存在问题，因为目前尚未制定内部 LEF 的标准测量，因此帕特森量表已用于评估内部肿胀。然而，帕特森量表未能捕获重要的解剖部位。此外，常用的成像技术（CT 扫描和超声检查）可以提供客观信号，以可视化口腔和颅面结构中与 LEF 相关的软组织变化。国家牙科和颅面研究所 (NIDCR) 2009-2013 年战略计划目标 III-1 尚未对各种方法在评估该人群中的 LEF 中的可能用途进行系统评估。 “进行精心设计、明确的临床研究，以改善口腔、牙齿和颅面健康，并支持更有效的护理服务和健康政策。”NIDCR 强调需要“开发新方法来实现这一目标”。 NIDCR 战略计划中，我们在试点研究中针对头颈部 LEF 制定了患者报告的结果测量方法和临床医生报告的结果测量方法。本研究的主要目标是建立有效的、临床上有用的头颈部测量方法。 LEF。具体目标是：1) 确定患者报告的结果测量 (LSIDS-H&N) 用于评估 LEF 相关症状的可靠性和有效性；2) 确定临床医生报告的结果测量 (HN-) 的可靠性和有效性。 LEF 分级标准和改良帕特森量表）用于评估外部和内部 LEF；3）确定成像技术（CT 扫描和灰度超声和应变弹性成像）在识别特定部位时的可靠性和有效性LEF 在口腔和口咽癌患者治疗、康复和生存过程中的作用我们计划通过以下方式招募 120 名参与者。一项为期四年的纵向研究将在治疗前、治疗结束以及癌症治疗后每 3 个月至 12 个月进行一次，如果我们的目标得以实现，合唱团将能够使用经过验证的措施。目的：1) 识别 LEF 相关症状；2) 转诊合适的患者接受 LEF 治疗；3) 为研究人员提供未来该领域研究急需的工具。