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Humanin

HN, S14G-Humanin

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Studies 491
Trials 100
Overview Studies Clinical Trials
Recruiting NA INTERVENTIONAL NCT06125743

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: Changes in severity of lymphedema and fibrosis
TimeFrame: Baseline, 3-, 6-, and 9-months post-intervention
Description: This outcome measure will be assessed via Head and Neck - External Lymphedema and Fibrosis Assessment Criteria (HN-LEF Assessment Criteria). The total severity score of lymphedema and fibrosis (LEF) is calculated by summing the severity score (normal = 0, mild =1, moderate =2, and severe =3) of each anatomical site affected by head and neck LEF. Higher scores mean a worse outcome.

Trial Information

NCT ID

NCT06125743

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Abramson Cancer Center at Penn Medicine

Last Updated

December 15, 2025