Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
NCT ID: NCT02676752
Last Updated: 2022-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2016-09-30
2021-08-31
Brief Summary
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Detailed Description
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I. To obtain pilot data of the elasticity of skin/soft tissues using shear wave elasticity at the defined anatomical sites in head and neck cancer survivors with lymphedema and fibrosis (LEF).
II. To explore the correlation between elasticity of skin/soft tissues and the following: 1) symptoms as measured by the Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-HN); 2) functional impact as measured by Cervical Range of Motion Device and the Vanderbilt Head and Neck Symptom Survey; and 3) physical exam findings as measured by Head and Neck LEF Grading Criteria.
OUTLINE:
Participants will be evaluated for LEF status using the Head and Neck External Lymphedema - Fibrosis (HN-LEF) Grading Criteria and neck range of motion using the Cervical Range of Motion Device. Participants also complete study questionnaires, including Vanderbilt Head and Neck Symptom Survey (VHNSS) and Lymphedema Symptom Intensity and Distress Survey - Head and Neck (LSIDS-H\&N). Participants undergo ultrasound shear wave elastography over 20-25 minutes. Participants' cancer disease and treatment information will be gathered from their medical records.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Skin/soft tissue elasticity assessment
Participants will be evaluated for LEF status using the HN-LEF Grading Criteria and neck range of motion using the Cervical Range of Motion Device. Participants also complete study questionnaires, including VHNSS and LSIDS-H\&N. Participants undergo ultrasound shear wave elastography over 20-25 minutes. Participants' cancer disease and treatment information will be gathered from their medical records.
Medical Examination
Evaluation of secondary lymphedema and fibrosis (LEF) status
Questionnaire Administration
Completion of questionnaires
Shear Wave Elastography
Undergo ultrasound shear wave elastrography
Interventions
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Medical Examination
Evaluation of secondary lymphedema and fibrosis (LEF) status
Questionnaire Administration
Completion of questionnaires
Shear Wave Elastography
Undergo ultrasound shear wave elastrography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completed all therapy
* No evidence of cancer (NED)
* Ability to understand English in order to complete questionnaires
* Able to provide informed consent
Exclusion Criteria
* Are unwilling to undergo the study assessment
* Have recurrent and/or metastatic cancer
22 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Kenneth Niermann
Principal Investigator
Principal Investigators
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Kenneth Niermann
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center
Locations
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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NCI-2016-00069
Identifier Type: REGISTRY
Identifier Source: secondary_id
VICC HN 15135
Identifier Type: OTHER
Identifier Source: secondary_id
VICC HN 15135
Identifier Type: -
Identifier Source: org_study_id
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