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

Abramson Cancer Center at Penn Medicine

Status: Enrolling

Conditions: Lymphedema of the Head and Neck

Treatments: Behavioral: Telehealth LEF-SMP; Behavioral: In-Person LEF-SMP; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06125743

UPCC# 12323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 3 patient groups

Usual Care

Other group

Treatment:

Behavioral: Usual Care

In-Person LEF-SMP

Experimental group

Treatment:

Behavioral: In-Person LEF-SMP

Telehealth LEF-SMP

Experimental group

Treatment:

Behavioral: Telehealth LEF-SMP