Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Lymphedema of the Head and Neck
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 204 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Usual Care
Not reported in this registry record.
Behavioral: Usual Care
In-Person LEF-SMP
Not reported in this registry record.
Behavioral: In-Person LEF-SMP
Telehealth LEF-SMP
Not reported in this registry record.
Behavioral: Telehealth LEF-SMP
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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 measures
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.
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).
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.
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.
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.
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.
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.
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).
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (2)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
2 locations
University of PennsylvaniaPhiladelphia, Pennsylvania, United StatesRecruiting
Vanderbilt University Medical CenterNashville, Tennessee, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Study start
- Mar 29, 2024 Actual
- Primary completion
- Aug 31, 2027 Estimated
- Study completion
- Aug 31, 2027 Estimated
- First posted
- Nov 9, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Promoting Self-Management in Head and Neck Cancer Survivors With Lymphedema and Fibrosis [PROMISE Trial]
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026