Clinical trial · Interventional
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Promoting Self-Management in Head and Neck Cancer Survivors With Lymphedema and Fibrosis [PROMISE Trial]
NCT06125743CI-TRIAL-00126047recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema of the Head and Neck | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| In-Person LEF-SMP | Behavioral | — | UNRESOLVED |
| Telehealth LEF-SMP | Behavioral | — | UNRESOLVED |
| Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Usual Care
- interventionNames
- Behavioral: Usual Care
- type
- EXPERIMENTAL
- label
- In-Person LEF-SMP
- interventionNames
- Behavioral: In-Person LEF-SMP
- type
- EXPERIMENTAL
- label
- Telehealth LEF-SMP
- interventionNames
- Behavioral: Telehealth LEF-SMP
Primary outcomes (1)
- measure
- Changes in severity of lymphedema and fibrosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDeng J, Abene J, Huang L, Murphy BA. Study protocol for a multi-site randomized clinical trial of an intervention program to promote self-management among head and neck cancer survivors with lymphedema and fibrosis [PROMISE trial]. Trials. 2025 Oct 13;26(1):404. doi: 10.1186/s13063-025-09089-x. PMID 41084063