Fibrosis, Lymphedema, Oral Cavity Cancer, Oropharyngeal Cancer
Conditions
Brief summary
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
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.
Interventions
OTHERLEF measures
Patient-reported outcome measure; clinician-reported outcome measures
PROCEDURETechnical measure
Undergo standard CT scan
Sponsors
National Cancer Institute (NCI)
National Institute of Dental and Craniofacial Research (NIDCR)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reliability of the patient-reported outcome measure (LSIDS-H&N) in terms of internal consistency of each symptom cluster | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The assessment will be conducted at pre-treatment, EOT, and every three months 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 | The assessment will be conducted at pre-treatment, EOT, and every three months up to 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 | The assessment will be conducted at pre-treatment, EOT, and every three months up to 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 | The assessment will be conducted at pre-treatment, and every three months up to 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 | 12 months after treatment | The assessment will be conducted at pre-treatment, and every three months up to 12 months after treatment |
Countries
United States
Outcome results
None listed