UPCC 20321 Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors: A Multi-Site Randomized Clinical Trial
Investigating Management of Lymphedema in Head and Neck Cancer Survivors
Brief description of study
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 of study
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
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Head and Neck Cancer, Lymphedema
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Age: 18 years or above
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Gender: All
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 moderate or severe carotid artery occlusion
- Significantly severe lymphedema (e.g., severe periorbital swelling)
- Conditions impacting the safe delivery of lymphedema therapy
This study investigates two different ways to manage lymphedema in individuals who have survived head and neck cancer. This study compares clinic-based Complete Decongestive Therapy (CDT) with a home-based hybrid model of CDT to see how each approach affects the severity of lymphedema in participants.
Participants will either receive CDT in a clinic or follow a home-based hybrid model. The study will measure changes in lymphedema severity, symptom burden, and functional status. It will also look at how often participants use healthcare services under each treatment method.
- Who can participate: Participants must be over 18 years old and have completed head and neck cancer treatment within the last 24 months. They should have a diagnosis of head and neck lymphedema, be referred by their oncology provider, and be able to perform self-manual lymphatic drainage. Access to an electronic device with internet is required.
- Study details: Participants will be randomly assigned to receive either clinic-based or home-based hybrid CDT. They will need to follow the respective therapy regimen and report on their symptoms and functional status. Participants should have access to a computer or smartphone for home-based activities.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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