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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
204
Participants will conduct self-care activities prescribed by their treating lymphedema therapists.
Participants will receive the in-person LEF-SMP intervention.
Participants will receive the telehealth LEF-SMP intervention.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGBarbara Murphy
Nashville, Tennessee, United States
RECRUITINGChanges 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.
Time frame: Baseline, 3-, 6-, and 9-months post-intervention
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, 3-, 6-, and 9-months post-intervention