Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Reduction in Swelling/Inflammation - Endoscopy |
The change in percent of sites with visible swelling and inflammation as assessed via endoscopy (using Modified Patterson Scale). The range for each anatomical structure includes 1-4: Normal, Mild, Moderate, and Severe. A lower score means a better outcome. A greater negative value indicates a greater reduction in swelling. Total score range: 0-100% |
Changes between Baseline, 2 months, 4 months, 6 months |
|
Primary |
Reduction in Swelling/Imaging - CT |
The changes in fat stranding, epiglottic thickness, and prevertebral soft tissue (PVST) using the CT Lymphedema and Fibrosis Assessment Tool (CT-LEFAT). The range for fat stranding includes 0-2: Normal, Mild Changes, Advanced Changes. A lower score means a better outcome. Epiglottis and PVST are measured in mm. A lower measurement means a better outcome. |
Changes between Baseline, 2 months, 6 months |
|
Primary |
Reduction in Swelling/Inflammation - Grading of External Lymphedema |
The presence of swelling and inflammation as assessed through grading of external lymphedema via the Head and Neck Lymphedema and Fibrosis Assessment criteria (HNLEF). A total of 9 sites are evaluated for the presence of lymphedema and graded from 1 (mild) to 3 (severe) at each site. The number of sites ranged from 0-9 with a total severity score ranging from 0-27. A lower score indicates a better outcome. A greater negative value indicates a greater reduction in swelling. |
Changes between Baseline, 2 months, 4 months, 6 months |
|
Primary |
Reduction in Swelling/Inflammation - Digital Photography |
The presence of swelling and inflammation are assessed by digital photography. A lower value means a better outcome. A greater negative value indicates a greater reduction in swelling. Three views are scored each with 30 grids. The percentage of views with visible swelling was determined. The score ranges from 0-100%. |
Changes between Baseline, 2 months, 4 months, 6 months |
|
Primary |
Symptom Burden - Lymphedema Symptom Intensity and Distress Survey |
Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-HN) assesses the measurement characteristics of a symptom burden for participants with head and neck lymphedema. Each symptom is rated on intensity and distress using a 5-point scale. A maximum response for any symptom within a given cluster will be used for the analysis. The total score ranged from 0-10. The values represent a change from baseline. A lower score means a better outcome. |
Changes between Baseline, 2 months, 4 months, 6 months |
|
Primary |
Symptom Burden and Functional Impairment - Vanderbilt Head and Neck Symptom Survey |
Vanderbilt Head and Neck Symptom Survey plus General Symptom Survey (VHNSS plus GSS) assesses symptom burden and functional impairment. Values represent a median score change from baseline. Score range: 0-10. A lower score indicates a better outcome. A more negative value indicates a greater change from baseline. |
Changes between Baseline, 2 months, 4 months, 6 months |
|
Primary |
Quality of Life - Linear Analog Self-Assessment |
Quality of life is assessed using the Linear Analog Self-Assessment. The total score for the assessment ranges from 0-50. Each category represents a change in score from the baseline visit which ranged from positive 4 to negative 4. A positive change indicates an improvement. |
Changes between Baseline, 2 months, 4 months, 6 months |
|
Primary |
Work and Activity - Work Productivity and Activity Impairment Questionnaire |
Work Productivity and Activity Impairment Questionnaire (WPAIQ) PRO assessment asks questions about work and activity impairment due to lymphedema and other health problems. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. Total score range: 0-100% |
Changes between Baseline, 2 months, 4 months, 6 months |
|
Primary |
Perceived self-management capacity - Perceived Medical Condition Self-Management Scale (PMCSMS) |
The 8-item Perceived Medical Condition Self-Management Scale (PMCSMS) is intended to measure patients' belief that they are capable of carrying out the self-management behaviors required by their medical condition. The scale is composed of four positively worded items and four negatively worded items, each rated on a five-point Likert scale (1=Strongly Disagree to 5=Strongly Agree). Negatively worded items are reversed scored, yielding a total score ranging from 8 to 40, with a higher score indicating stronger belief of perceived self-management competence. |
Changes between Baseline, 2 months, 4 months, 6 months |
|
Primary |
Body image - Body Image Quality of Life Inventory (BIQLI) |
Body Image Quality Life Inventory (BIQLI) assesses participants' body image using 7 point scale ranging from -3 (very negative) to +3 (very positive). Score range: -57 to 57. A higher score indicates a better outcome. |
Changes between Baseline, 2 months, 4 months, 6 months |
|
Primary |
Diet modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) |
Diet modifications will be assessed using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). The ASA24 is a tool from National Cancer Institute (NCI) that enables multiple automatically coded self-administered 24-hour recalls and food records. Changes in total caloric intake, fat, carbohydrate, fiber, sugars, and protein will be evaluated. |
Changes between Baseline, 2 months, 4 months, 6 months |
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