Clinical trial NCT05182229: Comparing Two Ways to Manage Head and Neck Lymphedema
Official title: Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lymphedema
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-01-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in severity of lymphedema
timeFrame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Secondary outcomes:
measure: Changes in severity of symptom burden
timeFrame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
measure: Changes in degrees of jaw range of motion
timeFrame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
measure: Changes in degrees of cervical range of motion
timeFrame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Other outcomes:
measure: Healthcare utilization
timeFrame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
measure: Healthcare utilization
timeFrame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Locations:
city: Cherry Hill
country: United States
facility: Jefferson Cherry Hospital Jefferson Health
state: New Jersey
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Torresdale Hospital Jefferson Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital and Fox Chase Cancer Center
state: Pennsylvania
city: Willow Grove
country: United States
facility: Asplundh Cancer Pavilion Jefferson Health
state: Pennsylvania
Study officials:
References: