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

NCT06125743 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-08-14

No results posted yet for this study

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.

Conditions

  • Lymphedema of the Head and Neck

Interventions

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-29
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06125743 on ClinicalTrials.gov