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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02412241
Other study ID # VICC SUPP 1529
Secondary ID 1R01DE024982-01
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date August 2020

Study information

Verified date March 2021
Source Vanderbilt-Ingram Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


Intervention

Other:
LEF measures
Patient-reported outcome measure; clinician-reported outcome measures
Procedure:
Technical measure
Undergo standard CT scan
Technical measure
Undergo standard ultrasound

Locations

Country Name City State
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee

Sponsors (3)

Lead Sponsor Collaborator
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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