Comparing Two Ways to Manage Head and Neck Lymphedema

Study Overview
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Brief Summary
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This randomized clinical trial aims to compare clinic-based CDT and home-based (a hybrid model) CDT on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in HNC survivors with lymphedema.

Detailed Description
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Primary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on changes in the severity of lymphedema. Secondary aim: To compare the effects of clinic-based and home-based (a hybrid model) CDT on symptom burden and functional status. Exploratory aim: To compare the healthcare utilization between patients receiving clinic-based versus home-based (a hybrid model) CDT

Official Title
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Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors

Conditions
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Head and Neck Cancer, Lymphedema

Intervention / Treatment
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* Other: Home-based (a hybrid model) CDT
* Other: Clinic-based CDT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age <=24 months post-HNC treatment Diagnosis of head and neck lymphedema and referral by their oncology providers Able to perform self-manual lymphatic drainage Having an electronic device (a computer, tablet, iPad, laptop, or smartphone) and internet access at home Exclusion Criteria: Active infection in soft tissues in the head and neck region History of carotid artery disease Significantly severe lymphedema (e.g., severe periorbital swelling) Conditions impacting the safe delivery of lymphedema therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinic-Based Lymphedema Therapy<br> | Other: Clinic-based CDT<br>* Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).<br>|
| Active Comparator: Home-Based (a hybrid model) Lymphedema Therapy<br> | Other: Home-based (a hybrid model) CDT<br>* Participants will be provided therapist-administered, in person complete decongestive therapy (CDT) two times per week for two weeks (4 sessions), followed by real-time, virtual CDT consultations two times per week for three weeks (7 sessions) and one in person follow-up visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in severity of lymphedema | Compare the effects of clinic-based and home-based CDT on changes in the severity of lymphedema. This outcome measure will be assessed via Head and Neck - External Lymphedema and Fibrosis Assessment Criteria (HN-LEF Assessment Criteria). | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in severity of symptom burden | Compare the effects of clinic-based and home-based CDT on changes in the severity of symptom burden. This outcome measure will be assessed via Head and Neck - Lymphedema and Fibrosis Symptom Inventory (HN-LEF Symptom Inventory) | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention | 
| Changes in degrees of jaw range of motion | Compare the effects of clinic-based and home-based CDT on jaw range of motion. Jaw range of motion will be measured via Jaw Range of Motion Scale. | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention | 
| Changes in degrees of cervical range of motion | Compare the effects of clinic-based and home-based CDT on cervical range of motion. Cervical Range of Motion will be measured via Cervical Range of Motion Instrument. | Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention |