Lymphedema, Lymphedema Due to Radiation, Lymphedema of Face, Lymphedema, Secondary, Lymphedema; Surgical
Conditions
Keywords
Head and Neck Lymphedema
Brief summary
To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.
Detailed description
Aim 1: To compare the short-term and long-term effectiveness of self-administered APCD therapy versus Usual Care in HNC survivors with treatment naive LEF on anatomical measures of internal and external LEF. Baseline measures will be obtained at the start of therapy. Short-term effectiveness will be evaluated at 2 months and long-term effectiveness will be evaluated at 4 and 6 months. Hypothesis: the APCD therapy will be associated with greater short-term and long-term reduction in anatomical measures of LEF. Aim 2: To compare the short-term and long-term effectiveness of self-administered APCD therapy versus Usual Care in HNC survivors with treatment naive LEF on patient reported biopsychosocial outcome measures impacted by LEF. Outcome measures will include: 1) symptom burden, 2) symptom burden and functional impairment, 3) quality of life (QOL), 4) work and activity, 5) perceived self-management capacity, 6) body image, and 7) diet modifications. Baseline measures will be obtained at the start of therapy. Short-term effectiveness will be evaluated at 2 months and long-term effectiveness will be evaluated at 4 and 6 months. Hypothesis: the APCD therapy will be associated with greater short-term and long-term improvement in patient reported biopsychosocial outcomes.
Interventions
Once daily treatment with Flexitouch Plus.
OTHERUsual Care
Usual care consists of a two-phase CDT. Phase 1 includes consultation with a lymphedema therapist, patient education, MLD, compression garments or bandages, skin care techniques, and a program of exercises and postural recommendations. Phase 2 consists of ongoing self-care, where patients conduct a life-long program of disease management that mimics the program in phase 1.
Sponsors
Tactile Medical
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary) 3. Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment 4. A diagnosis of either internal or external head and neck lymphedema 5. At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening 6. Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation 7. Must be able to speak and understand English
Exclusion criteria
1. Previous APCD or Usual Care treatment for HNC LEF 2. Acute facial infection (e.g., facial or parotid gland abscess) 3. Known carotid sinus hypersensitivity syndrome 4. Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness) 5. Internal jugular venous thrombosis (within 3 months) 6. Patient is pregnant or trying to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Internal Lymphedema - Endoscopy | Change from Baseline at 2 months, 4 months, 6 months | The change in average site score from baseline assessed via endoscopy using the Modified Patterson Scale. The range for each site was 0-3: Normal, Mild, Moderate, Severe. A lower score means a better outcome. |
| Internal Lymphedema - CT Imaging | Change from Baseline at 2 months, 6 months | The changes in fat stranding 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. |
| External Lymphedema - Head and Neck Lymphedema and Fibrosis Grading | Change from Baseline at 2 months, 4 months, 6 months | The presence of swelling and inflammation as assessed through grading of external lymphedema via the Head and Neck Lymphedema and Fibrosis Grading criteria (HN-LEFG). 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. |
| External Lymphedema - Digital Photography | Change from Baseline at 2 months, 4 months, 6 months | 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%. |
| Symptom Burden - Lymphedema Symptom Intensity and Distress Survey | Change from Baseline at 2 months, 4 months, 6 months | 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 (1-Slight to 5-Severe), then added together. The values represent the mean score change from baseline. Score range: 0-10 (0 = symptom not present). A lower score means a better outcome. |
| Physical Function - Vanderbilt Head and Neck Symptom Survey | Change from Baseline at 2 months, 4 months, 6 months | 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. |
| Quality of Life - Linear Analog Self-Assessment | Change from Baseline at 2 months, 4 months, 6 months | Quality of life is assessed using the Linear Analog Self-Assessment. The overall well-being score ranges from 0-10 (0-As bad as it can be to 10-As good as it can be). The value represents the change from baseline. A positive change indicates an improvement. |
| Work and Activity - Work Productivity and Activity Impairment Questionnaire | Change from Baseline at 2 months, 4 months, 6 months | Work Productivity and Activity Impairment Questionnaire (WPAIQ) PRO assessment asks questions about work and activity impairment due to lymphedema and other health problems. The values represent the difference from baseline percentage. A greater negative number indicates a greater reduction in impairment. Total score range: 0-100% |
| Perceived Self-management Capacity - Perceived Medical Condition Self-Management Scale | Change from Baseline at 2 months, 4 months, 6 months | 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. |
| Body Image - Body Image Quality of Life Inventory | Change from Baseline at 2 months, 4 months, 6 months | 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. The values represent the change from baseline. A higher score indicates a better outcome. |
| Diet Modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool | Change from Baseline at 2 months, 4 months, 6 months | 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 will be evaluated. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBarbara Murphy, MD
Vanderbilt University Medical Center
PRINCIPAL_INVESTIGATORSheila Ridner, RN, PhD
Vanderbilt University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.7 Years STANDARD_DEVIATION 9.8 |
| BMI | 26.8 kg/m^2 STANDARD_DEVIATION 6 |
| Cancer Site HNC of Unknown Primary | 5 Participants |
| Cancer Site Larynx | 35 Participants |
| Cancer Site Major Salivary Glands | 8 Participants |
| Cancer Site Oral Cavity | 57 Participants |
| Cancer Site Paranasal Sinuses | 2 Participants |
| Cancer Site Pharynx | 55 Participants |
| Race/Ethnicity, Customized American Indian | 1 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black | 17 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants |
| Race/Ethnicity, Customized Not Hispanic | 112 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 97 Participants |
| Region of Enrollment United States | 236 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 119 | 2 / 117 |
| other Total, other adverse events | 0 / 119 | 0 / 117 |
| serious Total, serious adverse events | 0 / 119 | 0 / 117 |
Outcome results
None listed