Comparing Two Ways to Manage Head and Neck Lymphedema

Abramson Cancer Center at Penn Medicine300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Head and Neck Cancer Lymphedema

Interventions

Home-based (a hybrid model) CDTOTHER

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 CDTOTHER

Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Jefferson Cherry Hospital Jefferson Health

Cherry Hill, New Jersey, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

RECRUITING

Jefferson Health

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Changes in severity of lymphedema

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).

Time frame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention

Secondary Outcomes

Changes in severity of symptom burden

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)

Time frame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention

Changes in degrees of jaw range of motion

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.

Time frame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention

Changes in degrees of cervical range of motion

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.

Time frame: Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention

Central Contacts

Jie Deng, PhD

CONTACT

215-573-2393 jiedeng@nursing.upenn.edu

Data from ClinicalTrials.gov

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