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

August 9, 2025 updated by: Abramson Cancer Center at Penn Medicine

Promoting Self-Management in Head and Neck Cancer Survivors With 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Barbara Murphy
        • Contact:
          • Barbara Murphy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual Care
Behavioral: Usual Care
Participants will conduct self-care activities prescribed by their treating lymphedema therapists.
Experimental: In-Person LEF-SMP
Behavioral: In-Person LEF-SMP
Participants will receive the in-person LEF-SMP intervention.
Experimental: Telehealth LEF-SMP
Behavioral: Telehealth LEF-SMP
Participants will receive the telehealth LEF-SMP intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3-, 6-, and 9-months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3-, 6-, and 9-months post-intervention
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.
Baseline, 3-, 6-, and 9-months post-intervention
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.
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
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).
Baseline, 3-, 6-, and 9-months post-intervention
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.
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 skills will be assessed via HN-LEF Skill Checklist. Study lymphedema therapists use this checklist to evaluate participants' LEF self-care skills.
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-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.
Baseline, 3-, 6-, and 9-months post-intervention
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).
Baseline, 3-, 6-, and 9-months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

November 5, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 9, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC# 12323

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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