Head and Neck Cancers

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

National Clinical Trial ID:: NCT06125743(opens in a new tab)
Protocol ID:: VICC-EDHAN23569
Primary Investigator:: Barbara Murphy
Phase:: N/A
Age Group:: Adults
Genders Eligible:: All
Cancer Type:: Head and Neck Cancers

Overview

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.

Who Can Participate

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

Disclaimer

This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.

Participation decisions can be made only after review by the study team and your treating clinician.