Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients

Conditions
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Oral Cavity Cancer, Oropharyngeal Cancer, Lymphedema, Fibrosis

Intervention / Treatment
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* Other: LEF measures
* Procedure: Technical measure
* Procedure: Technical measure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LEF Measures<br>PATIENT-REPORTED OUTCOME MEASURE: Validity of LSIDS-H&N will be assessed using 6 forms (e.g., Vanderbilt Head and Neck Symptom Survey (v2.0); Neck Disability Index; and Hospital Anxiety and Depression Scale). CLINICIAN-REPORTED OUTCOME MEASURES: External LEF will be assessed using HN-LEF Grading Criteria, CTCAE (v4.03), and digital photos of the head and neck. Internal LEF will be scored using Modified Patterson Scale through an endoscopic exam. Both external/internal measures are re-assessed for intrarater and interrater reliability. OBJECTIVE/TECHNICAL MEASURES: Patients undergo CT scans and ultrasound exams with results re-scored for intrarater and interrater reliability. | Other: LEF measures<br>* Patient-reported outcome measure; clinician-reported outcome measures<br>Procedure: Technical measure<br>* Undergo standard CT scan<br>* Other names: Computed Tomography (CT);Procedure: Technical measure<br>* Undergo standard ultrasound<br>* Other names: Ultrasonography, Ultrasound (US) Medical Ultrasound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster | The assessment will be conducted at pre-treatment, end of treatment (EOT), and every three months up to 12 months after treatment | Up to 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of the patient-reported outcome measure (LSIDS-H&N) in terms of content, construct, sensitivity to change, and clinical feasibility | The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment | Up to 12 months after treatment | 
| Reliability of the clinician-reported outcome measures (HN-LEF Grading criteria and the Modified Patterson Scale) | The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment | 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 | The assessment will be conducted at pre-treatment, EOT, and every three months up to 12 months after treatment | 12 months after treatment | 
| Reliability of imaging techniques in identifying site-specific LEF across the trajectory of treatment, recovery, and survival | The assessment will be conducted at pre-treatment, and every three months up to 12 months after treatment | 12 months after treatment | 
| 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 | The assessment will be conducted at pre-treatment, and every three months up to 12 months after treatment | 12 months after treatment |