This clinical trial compares the effect of clinic-based (therapy completed at a physical therapy clinic) to home-based (a hybrid model both in the clinic and self-care at home) in managing lymphedema that has developed after cancer treatments in head and neck cancer survivors. Lymphedema is the build-up of fluid in soft body tissues when the lymph system is damaged or blocked. A home-based, hybrid model may help reduce the severity of lymphedema in head and neck cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05182229.
PRIMARY OBJECTIVE:
I. To compare the effects of clinic-based and home-based complete decongestive therapy (CDT) on changes in the severity of lymphedema.
SECONDARY OBJECTIVE:
I. To compare the effects of clinic-based and home-based CDT on symptom burden and functional status.
EXPLORATORY OBJECTIVE:
I. To compare the healthcare utilization between patients receiving clinic-based versus home-based CDT.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1 (CLINIC-BASED): Patients receive therapist-administered, in-person complete decongestive therapy (CDT) twice weekly for 6 weeks.
ARM 2 (HOME-BASED): Patients receive therapist-administered, in-person CDT twice weekly for 2 weeks, followed by real-time video CDT consultations twice weekly for 3 weeks.
After completion of study treatment, patients are followed up at 6 months and 12 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorJie Deng
