Comparing Two Ways to Manage Head and Neck Lymphedema
- Conditions
- LymphedemaHead and Neck Cancer
- Interventions
- Other: Clinic-based CDTOther: Home-based (a hybrid model) CDT
- Registration Number
- NCT05182229
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- >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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clinic-Based Lymphedema Therapy Clinic-based CDT - Home-Based (a hybrid model) Lymphedema Therapy Home-based (a hybrid model) CDT -
- Primary Outcome Measures
Name Time Method Changes in severity of lymphedema Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention 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).
- Secondary Outcome Measures
Name Time Method Changes in degrees of jaw range of motion Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention 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.
Changes in degrees of cervical range of motion Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention 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.
Changes in severity of symptom burden Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention 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)
Trial Locations
- Locations (6)
Jefferson Cherry Hospital Jefferson Health
🇺🇸Cherry Hill, New Jersey, United States
Jefferson Torresdale Hospital Jefferson Health
🇺🇸Philadelphia, Pennsylvania, United States
Asplundh Cancer Pavilion Jefferson Health
🇺🇸Willow Grove, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Jefferson Health
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital and Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States