Comparing Two Ways to Manage Head and Neck Lymphedema

NCT05182229 — Not applicable, Active not recruiting, 240 participants, Abramson Cancer Center at Penn Medicine

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Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors

RegistryNCT05182229
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment240 (Actual)
SponsorAbramson Cancer Center at Penn Medicine (Other); collaborators: Patient-Centered Outcomes Research Institute
ConditionsHead and Neck Cancer, Lymphedema
InterventionsHome-based (a hybrid model) CDT, Clinic-based CDT (Other)
Datesstart 2022-03-11, primary completion 2027-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2022-01-10, last updated 2026-05-06
Locations6 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

-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.

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+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

+Arms and interventions

ArmTypeInterventionsDescription
Clinic-Based Lymphedema TherapyActive comparatorOther: Clinic-based CDT
Home-Based (a hybrid model) Lymphedema TherapyActive comparatorOther: Home-based (a hybrid model) CDT
  • Home-based (a hybrid model) CDT (Other): Participants will be provided therapist-administered, in person complete decongestive therapy (CDT) two times per week for two weeks (4 sessions), followed by real-time, virtual CDT consultations two times per week for three weeks (7 sessions) and one in person follow-up visit.
  • Clinic-based CDT (Other): Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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)
  • 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.

Other outcomes

  • Healthcare utilization [Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention]: Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Healthcare Utilization Questionnaire will be used in this study.
  • Healthcare utilization [Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention]: Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Electronic Health Records (EHR) will be used in this study.

+Eligibility

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

+Locations (6)

FacilityCityCountryStatus
Jefferson Cherry Hospital Jefferson HealthCherry Hill, New JerseyUnited States
University of PennsylvaniaPhiladelphia, PennsylvaniaUnited States
Jefferson HealthPhiladelphia, PennsylvaniaUnited States
Jefferson Torresdale Hospital Jefferson HealthPhiladelphia, PennsylvaniaUnited States
Temple University Hospital and Fox Chase Cancer CenterPhiladelphia, PennsylvaniaUnited States
Asplundh Cancer Pavilion Jefferson HealthWillow Grove, PennsylvaniaUnited States