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

• 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
• 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

 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率;然而，改善的结局通常以显著的急性和晚期治疗效果为代价。该人群中常见但未充分识别的晚期效应是水肿和纤维化（LEF）。LEF可以涉及外部（例如，面）和内部结构（例如，舌头）。LEF严重程度与大量症状负担、功能障碍和生活质量下降相关。然而，在口腔和口咽癌患者中测量LEF具有挑战性。目前，没有心理测量学验证的患者报告的结果措施可用于评估LEF在这一人群中。我们最近的出版物表明，现有的临床医生报告的外部头部和颈部LEF的结局指标是有问题的。Patterson量表已在少数研究中用于评价内部肿胀，因为目前尚未开发内部LEF的标准测量。然而，Patterson量表未能捕获重要的解剖部位（例如，口腔舌），可能发展内部LEF。此外，常用的成像技术（CT扫描和超声检查）可以提供客观的信号，以可视化LEF相关的软组织变化的口腔和颅面结构。然而，这些常用的成像方式尚未进行系统评价，可能用于评估LEF在这一人群中。国家牙科和颅面研究所（NIDCR）2009-2013年战略计划，目标III-1指出：“进行精心设计的，明确的临床研究，改善口腔，牙齿和颅面健康，并支持更有效的护理服务和卫生政策。NIDCR强调有必要“开发新的方法来实现这一目标。”“为了与NIDCR战略计划保持一致，我们在我们的试点研究中为头颈部LEF制定了患者报告的结局指标和临床医生报告的结局指标。本研究的主要目标是建立一个有效的，临床上有用的测量电池的头部和颈部左心房颤动。具体目标是：1）确定患者报告结局指标的可靠性和有效性（LSIDS-H&N）用于评估LEF相关症状; 2）确定临床医生报告的结局指标的可靠性和有效性（HN- LEF分级标准和改良Patterson量表）用于评估外部和内部LEF;和3）确定成像技术的可靠性和有效性（CT扫描和超声与灰度和应变弹性成像）在整个治疗过程中识别口腔和口咽癌患者中的部位特异性LEF，恢复和生存。我们计划招募120名参与者， 一项为期四年的纵向研究数据收集将在治疗前、治疗结束时以及癌症治疗后每3个月至12个月进行一次。如果我们的目标得以实现，临床医生将能够使用经验证的措施：1）识别LEF相关症状; 2）推荐适当的患者进行LEF治疗; 3）监测治疗结果。将为研究人员提供这一领域未来调查所急需的工具。