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.

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NCT06125743

Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]

Recruiting
NAAges 18+InterventionalSupportive care
Abramson Cancer Center at Penn Medicine
~204 participants
Updated 2025-08-14 on ClinicalTrials.gov
What's tested:Usual CareIn-Person LEF-SMPTelehealth LEF-SMP

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in severity of lymphedema and fibrosis
Measured over Baseline, 3-, 6-, and 9-months post-intervention
Lymphedema of the Head and Neck
2 sites across 2 states
Pennsylvania1
Tennessee1

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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
  • 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.