Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Purpose
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 burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.
Condition
- Lymphedema of the Head and Neck
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- >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 Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Usual Care |
|
|
|
Experimental In-Person LEF-SMP |
|
|
|
Experimental Telehealth LEF-SMP |
|
Recruiting Locations
Nashville, Tennessee 37232
Barbara Murphy, MD
More Details
- Status
- Recruiting
- Sponsor
- Abramson Cancer Center at Penn Medicine
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 in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF-related symptom burden, functional impairments, and quality of life; and 3) compare the effects of in-person LEF-SMP, telehealth LEF-SMP, and usual care on LEF-related knowledge, skills, self-efficacy, and self-care adherence.