Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Neoplasms

Lymphedema

Fibrosis

Head and Neck Neoplasms

Lymphatic Diseases

Participants will conduct self-care activities prescribed by their treating lymphedema therapists.

Usual Care

Participants will receive the in-person LEF-SMP intervention.

In-Person LEF-SMP

Participants will receive the telehealth LEF-SMP intervention.

Telehealth LEF-SMP

Jie Deng, PhD

Barbara Murphy, MD

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.

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

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

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.

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.

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).

This outcome measure will be assessed via Cervical Range of Motion Instrument. Higher degrees of cervical range of motion mean a better outcome.

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.

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.

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 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 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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]	NCT06125743	Lymphedema of t...	Usual Care In-Person LEF-S... Telehealth LEF-...	18 Years -	Abramson Cancer Center at Penn Medicine
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]	NCT06125743	Lymphedema of t...	Usual Care In-Person LEF-S... Telehealth LEF-...	18 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for lymphedema of the head and neck