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Recruiting NCT06125743

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

No phase Interventional Lymphedema of the Head and Neck

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Usual Care, In-Person LEF-SMP, Telehealth LEF-SMP.
Who it may be relevant to
Registry conditions: Lymphedema of the Head and Neck. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Promoting Self-Management in Head and Neck Cancer Survivors With Lymphedema and Fibrosis [PROMISE Trial]

Overview

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.

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.

Interventions

  • Behavioral Usual Care
    Participants will conduct self-care activities prescribed by their treating lymphedema therapists.
  • Behavioral In-Person LEF-SMP
    Participants will receive the in-person LEF-SMP intervention.
  • Behavioral Telehealth LEF-SMP
    Participants will receive the telehealth LEF-SMP intervention.

Primary outcome measures

  • Changes in severity of lymphedema and fibrosis [Time frame: Baseline, 3-, 6-, and 9-months post-intervention]
Secondary outcome measures (8)
  • Changes in severity of symptom burden [Time frame: Baseline, 3-, 6-, and 9-months post-intervention]
  • Changes in degrees of jaw range of motion [Time frame: Baseline, 3-, 6-, and 9-months post-intervention]
  • Changes in degrees of cervical range of motion [Time frame: Baseline, 3-, 6-, and 9-months post-intervention]
  • Changes in quality-of-life score [Time frame: Baseline, 3-, 6-, and 9-months post-intervention]
  • Changes in LEF-related knowledge score [Time frame: Baseline, 3-, 6-, and 9-months post-intervention]
  • Changes in LEF-related skills [Time frame: Baseline, 3-, 6-, and 9-months post-intervention]
  • LEF-related self-efficacy score [Time frame: Baseline, 3-, 6-, and 9-months post-intervention]
  • LEF-related self-care adherence status [Time frame: Baseline, 3-, 6-, and 9-months post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • University of Pennsylvania — Philadelphia
  • Barbara Murphy — Nashville

Publications

  • Deng 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

Identifiers

NCT: NCT06125743 · UPCC# 12323

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗