Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
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|ClinicalTrials.gov Identifier: NCT02676752|
Recruitment Status : Recruiting
First Posted : February 8, 2016
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment|
|Lymphedema||Procedure: Medical Examination Other: Questionnaire Administration Procedure: Shear Wave Elastography|
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Assessing Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
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.
Procedure: Medical Examination
Evaluation of secondary lymphedema and fibrosis (LEF) status
Other: Questionnaire Administration
Completion of questionnaires
Procedure: Shear Wave Elastography
Undergo ultrasound shear wave elastrography
Other Name: Transient Elastography
- Elasticity values [ Time Frame: Within 2 weeks of initial study visit ]Descriptive statistics will be used to describe data from elasticity measure. Of particular interest will be the measures of central tendency and variability at the multiple sites. Sites with higher variability (coefficient of variation) that others may be indicative of less reliable assessment.
- Strength of associations of tissue elasticity and current conventional methods [ Time Frame: Within 2 weeks of initial study visit ]Correlation coefficients will be used to assess the strength of the associations of the elasticity values with the respective LEF grades (HN-LEF) for the respective sites. Those values will also be correlated with Vanderbilt Head and Neck Symptom Survey and HN-LSIDS symptom and Cervical Range of Motion scores. Due to the large number of correlations proposed in this study, effect sizes (strength of the associations) and clinically significant patterns will be of much greater importance than statistical significance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676752
|Contact: Vanderbilt-Ingram Service for Timely Access||800-811-8480|
|United States, Tennessee|
|Vanderbilt University/Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Kenneth J. Niermann 615-322-2555 firstname.lastname@example.org|
|Principal Investigator: Kenneth J. Niermann|
|Principal Investigator:||Kenneth Niermann||Vanderbilt University/Ingram Cancer Center|