Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
- Conditions
- Lymphedema of the Head and Neck
- Registration Number
- NCT06125743
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 204
- >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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes in severity of lymphedema and fibrosis 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 Outcome Measures
Name Time Method Changes in severity of symptom burden 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 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 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 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 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 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 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 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).
Trial Locations
- Locations (2)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Barbara Murphy
🇺🇸Nashville, Tennessee, United States
University of Pennsylvania🇺🇸Philadelphia, Pennsylvania, United StatesJie Deng, PhDContact215-573-2393jiedeng@nursing.upenn.edu