RecruitingNot ApplicableNCT06125743

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]


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

204 participants

Start Date

Mar 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called the PROMISE Trial) is testing a self-management program for people with swelling and scarring (lymphedema and fibrosis) in the head and neck area after treatment for head and neck cancer, especially for those who cannot easily access in-person therapy. **You may be eligible if:** - You are over 18 years old - You have completed your main cancer treatment for head and neck cancer with no signs of cancer remaining - You have completed initial lymphedema therapy but still face barriers to accessing it - You have a history of lymphedema in the face/neck, with or without scarring - You can read and understand English - You have a device (smartphone, tablet, or computer) with internet access at home **You may NOT be eligible if:** - Your cancer has come back or spread - You have another active cancer - You have an active infection, acute heart failure, or acute kidney failure - You have swelling in the lungs (cardiac or pulmonary edema) - You have a sensitive or severely blocked carotid artery, uncontrolled blood pressure, or venous blood clots - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALUsual Care

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

BEHAVIORALIn-Person LEF-SMP

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

BEHAVIORALTelehealth LEF-SMP

Participants will receive the telehealth LEF-SMP intervention.


Locations(2)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Barbara Murphy

Nashville, Tennessee, United States

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NCT06125743


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