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

RECRUITINGN/ASponsored by Abramson Cancer Center at Penn Medicine
Actively Recruiting
PhaseN/A
SponsorAbramson Cancer Center at Penn Medicine
Started2024-03-29
Est. completion2026-08-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerLymphedema of the Head and Neck

Locations2 sites

Pennsylvania

1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jie Deng, PhD215-573-2393jiedeng@nursing.upenn.edu

Tennessee

1 site
Barbara Murphy
Nashville, Tennessee, 37232
Barbara Murphy, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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