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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Other |
| |
| In-Person LEF-SMP | Experimental |
| |
| Telehealth LEF-SMP | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Behavioral | Participants will conduct self-care activities prescribed by their treating lymphedema therapists. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Deng, PhD | Contact | 2155732393 | jiedeng@nursing.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41084063 | Derived | Deng J, Abene J, Huang L, Murphy BA. Study protocol for a multi-site randomized clinical trial of an intervention program to promote self-management among head and neck cancer survivors with lymphedema and fibrosis [PROMISE trial]. Trials. 2025 Oct 13;26(1):404. doi: 10.1186/s13063-025-09089-x. |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D005355 | Fibrosis |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
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| 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 |
| Barbara Murphy | Recruiting | Nashville | Tennessee | 37232 | United States |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |