Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Lymphedema
Type
Observational
Design
Observational Model: Case-OnlyTime Perspective: Cross-Sectional

Participation Requirements

Age
Between 22 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: 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 followin...

PRIMARY OBJECTIVES: 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.

Tracking Information

NCT #
NCT02676752
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kenneth Niermann Vanderbilt University/Ingram Cancer Center