Lymphedema of the Head and Neck
Conditions
Keywords
Lymphedema, Fibrosis, Head and Neck Cancer, Survivorship, Self-Management
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.
Interventions
BEHAVIORALUsual Care
Participants will conduct self-care activities prescribed by their treating lymphedema therapists.
BEHAVIORALIn-Person LEF-SMP
Participants will receive the in-person LEF-SMP intervention.
BEHAVIORALTelehealth LEF-SMP
Participants will receive the telehealth LEF-SMP intervention.
Sponsors
Abramson Cancer Center at Penn Medicine
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
CONTACTJie Deng, PhD
Outcome results
None listed