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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphedema of the Head and Neck

Intervention / Treatment
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* Behavioral: Usual Care
* Behavioral: In-Person LEF-SMP
* Behavioral: Telehealth LEF-SMP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in severity of lymphedema and fibrosis | 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 severity of symptom burden | 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 | 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 degrees of cervical range of motion | 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 | 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 LEF-related knowledge score | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphedema, Fibrosis, Head and Neck Cancer, Survivorship, Self-Management