Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06125743

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lymphedema of the Head and Neck Fibrosis Head and Neck Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Behavioral

Participants will conduct self-care activities prescribed by their treating lymphedema therapists.

In-Person LEF-SMP

Behavioral

Participants will receive the in-person LEF-SMP intervention.

Telehealth LEF-SMP

Behavioral

Participants will receive the telehealth LEF-SMP intervention.

Primary outcomes

  1. Changes in severity of lymphedema and fibrosis

    Time frame: Baseline, 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.

Secondary outcomes

  1. Changes in severity of symptom burden

    Time frame: Baseline, 3-, 6-, and 9-months post-intervention

    This outcome measure will be assessed via Head and Neck - Lymphedema and Fibrosis Symptom Inventory (HN-LEF Symptom Inventory). The severity score of symptom burden is dependent on the number of self-reported symptoms [overall score range: 0 (no) - 5 (severe)], and higher scores mean a worse outcome.

  2. Changes in degrees of jaw range of motion

    Time frame: Baseline, 3-, 6-, and 9-months post-intervention

    This outcome measure will be assessed via Jaw Range of Motion Scale. Higher degrees of jaw range of motion mean a better outcome (criteria for trismus: mouth opening < 35mm).

  3. Changes in degrees of cervical range of motion

    Time frame: Baseline, 3-, 6-, and 9-months post-intervention

    This outcome measure will be assessed via Cervical Range of Motion Instrument. Higher degrees of cervical range of motion mean a better outcome.

  4. Changes in quality-of-life score

    Time frame: Baseline, 3-, 6-, and 9-months post-intervention

    This outcome measure will be assessed via European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This questionnaire includes a global health-related quality of life scale, 5 functional subscales, 3 symptom scales, and 6 single items. Scores for all scales and single items are linearly converted to range from 0-100, and higher scores signify a higher quality of life.

  5. Changes in LEF-related knowledge score

    Time frame: Baseline, 3-, 6-, and 9-months post-intervention

    LEF-related knowledge will be assessed via HN-LEF Knowledge Test scale. The scale asks participants to answer 35 true/false questions. The total score (score range: 0-35) represents participants' knowledge level related to head and neck LEF, and higher scores mean a better outcome.

  6. Changes in LEF-related skills

    Time frame: Baseline, 3-, 6-, and 9-months post-intervention

    LEF-related skills will be assessed via HN-LEF Skill Checklist. Study lymphedema therapists use this checklist to evaluate participants' LEF self-care skills.

  7. LEF-related self-efficacy score

    Time frame: Baseline, 3-, 6-, and 9-months post-intervention

    LEF-related self-efficacy will be assessed via Perceived Medical Condition Self-Management Scale [8-item, each item score 1 (strongly disagree) - 5 (strongly agree)]. Higher scores indicate greater self-efficacy.

  8. LEF-related self-care adherence status

    Time frame: Baseline, 3-, 6-, and 9-months post-intervention

    LEF-related self-care adherence will be assessed via LEF Self-Care Checklist. Higher scores indicate greater better adherence to LEF self-care activities (i.e., full adherence: ≥ 5 days; partial adherence: 3-4 days; non-adherence: <3 days).

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Deng, PhD

CONTACT

[email protected]

2155732393

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 9, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.