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.
Brief Title
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Lymphedema
Lymphedema of Face
Lymphedema, Secondary
Lymphedema Due to Radiation
Lymphedema; Surgical
Eligibility Criteria
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
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
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Keywords
Head and Neck Lymphedema
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04797390
Org Class
Industry
Org Full Name
Tactile Medical
Org Study Id
8030
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized Trial of an Advanced Pneumatic Compression Device vs. Usual Care for Head and Neck Lymphedema
Primary Outcomes
Outcome Description
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%
Outcome Measure
Reduction in Swelling/Inflammation - Endoscopy
Outcome Time Frame
Changes between Baseline, 2 months, 4 months, 6 months
Outcome Description
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.
Outcome Measure
Reduction in Swelling/Imaging - CT
Outcome Time Frame
Changes between Baseline, 2 months, 6 months
Outcome Description
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.
Outcome Measure
Reduction in Swelling/Inflammation - Grading of External Lymphedema
Outcome Time Frame
Changes between Baseline, 2 months, 4 months, 6 months
Outcome Description
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%.
Outcome Measure
Reduction in Swelling/Inflammation - Digital Photography
Outcome Time Frame
Changes between Baseline, 2 months, 4 months, 6 months
Outcome Description
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.
Outcome Measure
Symptom Burden - Lymphedema Symptom Intensity and Distress Survey
Outcome Time Frame
Changes between Baseline, 2 months, 4 months, 6 months
Outcome Description
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.
Outcome Measure
Symptom Burden and Functional Impairment - Vanderbilt Head and Neck Symptom Survey
Outcome Time Frame
Changes between Baseline, 2 months, 4 months, 6 months
Outcome Description
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.
Outcome Measure
Quality of Life - Linear Analog Self-Assessment
Outcome Time Frame
Changes between Baseline, 2 months, 4 months, 6 months
Outcome Description
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%
Outcome Measure
Work and Activity - Work Productivity and Activity Impairment Questionnaire
Outcome Time Frame
Changes between Baseline, 2 months, 4 months, 6 months
Outcome Description
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.
Outcome Measure
Perceived self-management capacity - Perceived Medical Condition Self-Management Scale (PMCSMS)
Outcome Time Frame
Changes between Baseline, 2 months, 4 months, 6 months
Outcome Description
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.
Outcome Measure
Body image - Body Image Quality of Life Inventory (BIQLI)
Outcome Time Frame
Changes between Baseline, 2 months, 4 months, 6 months
Outcome Description
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.
Outcome Measure
Diet modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Outcome Time Frame
Changes between Baseline, 2 months, 4 months, 6 months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Thomas Ow
Investigator Email
THOW@MONTEFIORE.ORG
Investigator Phone
718-920-5450 / 718-920-8488