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NCT05182229 Clinical Trial

Comparing Two Ways to Manage Head and Neck Lymphedema

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05182229
Other study ID # UPCC 20321
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 11, 2022
Est. completion date October 31, 2024

Study information
Verified date August 2023
Source Abramson Cancer Center at Penn Medicine
Contact Jie Deng, PhD
Phone 215-573-2393
Email jiedeng@nursing.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 300
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 carotid artery disease - Significantly severe lymphedema (e.g., severe periorbital swelling) - Conditions impacting the safe delivery of lymphedema therapy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Home-based (a hybrid model) CDT
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
Participants will be provided therapist administered, in-person CDT two times per week for six weeks (12 sessions).

Locations
Country Name City State
United States Temple University Hospital and Fox Chase Cancer Center Philadelphia Pennsylvania
United States Thomas Jefferson University Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Healthcare utilization Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Healthcare Utilization Questionnaire will be used in this study. Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Other Healthcare utilization Compare healthcare utilization between patients receiving clinic-based versus home-based CDT. Electronic Health Records (EHR) will be used in this study. Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Primary 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). Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Secondary 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) Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Secondary 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. Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
Secondary 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. Baseline, Immediately after End of Intervention (an average of 6 weeks), 6-Month Post-Intervention, 12-Month Post-Intervention
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