Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors
| Registry | NCT05182229 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 240 (Actual) |
| Sponsor | Abramson Cancer Center at Penn Medicine (Other); collaborators: Patient-Centered Outcomes Research Institute |
| Conditions | Head and Neck Cancer, Lymphedema |
| Interventions | Home-based (a hybrid model) CDT, Clinic-based CDT (Other) |
| Dates | start 2022-03-11, primary completion 2027-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2022-01-10, last updated 2026-05-06 |
| Locations | 6 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Head and Neck Cancer All trials for Lymphedema All trials of Home-based (a hybrid model) CDT All trials of Clinic-based CDT
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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Clinic-Based Lymphedema Therapy | Active comparator | Other: Clinic-based CDT | |
| Home-Based (a hybrid model) Lymphedema Therapy | Active comparator | Other: Home-based (a hybrid model) CDT |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Jefferson Cherry Hospital Jefferson Health | Cherry Hill, New Jersey | United States | |
| University of Pennsylvania | Philadelphia, Pennsylvania | United States | |
| Jefferson Health | Philadelphia, Pennsylvania | United States | |
| Jefferson Torresdale Hospital Jefferson Health | Philadelphia, Pennsylvania | United States | |
| Temple University Hospital and Fox Chase Cancer Center | Philadelphia, Pennsylvania | United States | |
| Asplundh Cancer Pavilion Jefferson Health | Willow Grove, Pennsylvania | United States |