NCT06125743

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]

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphedema of the Head and Neck

Interventions

Type	Name	Description
BEHAVIORAL	Usual Care	Participants will conduct self-care activities prescribed by their treating lymphedema therapists.
BEHAVIORAL	In-Person LEF-SMP	Participants will receive the in-person LEF-SMP intervention.
BEHAVIORAL	Telehealth LEF-SMP	Participants will receive the telehealth LEF-SMP intervention.

Timeline

• Start date: 2024-03-29
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2023-11-09
• Last updated: 2025-08-14

Locations

2 sites across 1 country: United States