Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster
研究概览
简要总结
This four-year, prospective, longitudinal study will evaluate and validate a patient-reported outcome measure, clinician-reported outcome measures, and imaging techniques in assessing characteristics, trajectory, and progression of lymphedema and fibrosis (LEF) in oral cavity and oropharyngeal cancer patients.
This clinical trial studies patient-and-clinician-reported measures as well as standard imaging methods to see how accurate they are in identifying and evaluating lymphedema (swelling) or fibrosis (tough or tight tissue) in the head and neck region of patients receiving treatment for newly diagnosed stage II-IV oral cavity or oropharyngeal cancer. Lymphedema and fibrosis (LEF) can lead to physical symptoms, such as trouble swallowing and chewing, as well as psychological and emotional symptoms, such as negative body image and avoiding social interactions. Finding an accurate test to identify and evaluate LEF may allow doctors to treat LEF more quickly and control symptoms more effectively, and thus provide patients with a better quality of life.
详细描述
The goal of this proposed study is to establish a valid, clinically useful measurement battery for head and neck LEF by achieving these specific aims:
Aim 1: To determine the reliability and validity of the patient-reported outcome measure (LSIDS-H&N) for assessing LEF-related symptoms in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
Aim 2: To 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 in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
Aim 3: To determine the reliability and validity of imaging techniques (CT scan and ultrasonography) in identifying site-specific LEF in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a newly diagnosed, histologically proven cancer arising from the oral cavity and oropharynx
- •tumor stage II or greater
- •age ≥ 21 years old
- •willing and able to undergo study assessment
- •able to speak and read English and understand Informed Consent.
排除标准
- •have medical record documentation of cognitive impairment that would preclude the ability to provide informed consent
- •are unwilling to undergo routine follow-up
- •have recurrent cancer
- •have any other active cancer.
结局指标
主要结局
Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster
时间窗: Up to 12 months after treatment
The assessment will be conducted at pre-treatment, end of treatment (EOT), and every three months up to 12 months after treatment
次要结局
- Validity of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival, in terms of concordance correlation, sensitivity to change, and clinical feasibility(12 months after treatment)
- Validity of the patient-reported outcome measure (LSIDS-H&N) in terms of content, construct, sensitivity to change, and clinical feasibility(Up to 12 months after treatment)
- Reliability of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale)(12 months after treatment)
- Validity of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale) in terms of criteria correlations, sensitivity to change, and clinical feasibility(12 months after treatment)
- Reliability of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival(12 months after treatment)
研究者
Jie Deng
Assistant Professor
Vanderbilt-Ingram Cancer Center