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NCT06125743NARecruiting

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

Abramson Cancer Center at Penn Medicine

Start Date

3/29/2024

Completion Date

8/31/2026

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Usual Care

BEHAVIORAL

In-Person LEF-SMP

BEHAVIORAL

Telehealth LEF-SMP

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Conditions

Lymphedema of the Head and Neck

Locations

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Barbara Murphy

Nashville, Tennessee 37232

United States