Status:
RECRUITING
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
United States Department of Defense
Conditions:
Lymphedema of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom bur...
Detailed Description
In HNC survivors with lymphedema and fibrosis (LEF), the investigators will: 1) compare the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF severity; 2) compare the effects of ...
Eligibility Criteria
Inclusion
- \>18 years of age
- Post HNC primary treatment
- No evidence of cancer (NED)
- Completion of initial lymphedema therapy for head and neck lymphedema
- Unable to obtain lymphedema therapy due to barriers noted above
- History of lymphedema on the face and neck, with or without fibrosis
- Ability to understand English in order to complete questionnaires
- Ability to perform self-care activities for LEF management
- Ability to provide informed consent
- Having an electronic device (a computer, tablet, iPad, or smartphone) and internet access at home
- A valid email address
Exclusion
- Recurrent or metastatic cancer
- Any other active cancer
- Acute infection
- Acute congestive heart failure
- Acute renal failure
- Cardiac or pulmonary edema
- Sensitive carotid sinus
- Severe carotid blockage
- Uncontrolled hypertension
- Venous thrombosis
- Pregnant people
- Incarcerated patients
Key Trial Info
Start Date :
March 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06125743
Start Date
March 29 2024
End Date
August 31 2026
Last Update
August 14 2025
Active Locations (2)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
Barbara Murphy
Nashville, Tennessee, United States, 37232