Self-Management for Head and Neck Lymphedema and Fibrosis (PROMISE Trial)
This study, called the PROMISE Trial, is looking at different ways to help people manage lymphedema and fibrosis in their head and neck after cancer treatment. It compares two self-management programs (LEF-SMP), one in-person and one through telehealth, against usual care. The goal is to see if these programs can improve how you manage your lymphedema and fibrosis, reduce symptoms, help with daily activities, and improve your quality of life. You might be able to join if you are over 18, have finished your head and neck cancer treatment, have no signs of cancer, and have head and neck lymphedema with or without fibrosis. The study will measure changes in the severity of your lymphedema and fibrosis over 9 months to see if the programs are successful. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll 204 participants. It compares three groups: in-person LEF-SMP, telehealth LEF-SMP, and usual care.
- What's involved
- Participants will engage in self-care activities prescribed by therapists or receive one of the LEF-SMP interventions. Measurements will be taken at the start, then at 3, 6, and 9 months after the intervention.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 9 months after their intervention to assess changes in lymphedema and fibrosis severity.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Changes in severity of lymphedema and fibrosisBaseline, 3-, 6-, and 9-months post-intervention
This outcome measure will be assessed via Head and Neck - External Lymphedema and Fibrosis Assessment Criteria (HN-LEF Assessment Criteria). The total severity score of lymphedema and fibrosis (LEF) is calculated by summing the severity score (normal = 0, mild =1, moderate =2, and severe =3) of each anatomical site affected by head and neck LEF. Higher scores mean a worse outcome.