Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age
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Post HNC primary treatment
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No evidence of cancer (NED)
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Completion of initial lymphedema therapy for head and neck lymphedema
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Unable to obtain lymphedema therapy due to barriers noted above
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History of lymphedema on the face and neck, with or without fibrosis
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Ability to understand English in order to complete questionnaires
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Ability to perform self-care activities for LEF management
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Ability to provide informed consent
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Having an electronic device (a computer, tablet, iPad, or smartphone) and internet access at home
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A valid email address
Exclusion Criteria:
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Recurrent or metastatic cancer
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Any other active cancer
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Acute infection
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Acute congestive heart failure
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Acute renal failure
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Cardiac or pulmonary edema
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Sensitive carotid sinus
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Severe carotid blockage
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Uncontrolled hypertension
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Venous thrombosis
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Pregnant people
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Incarcerated patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 2 | Barbara Murphy | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Abramson Cancer Center at Penn Medicine
- United States Department of Defense
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UPCC# 12323