NCT06125743

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2024Aug 2026

First Submitted

Initial submission to the registry

November 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 29, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

November 1, 2023

Last Update Submit

August 9, 2025

Conditions

Lymphedema of the Head and Neck

Keywords

LymphedemaFibrosisHead and Neck CancerSurvivorshipSelf-Management

Outcome Measures

Primary Outcomes (1)

  • Changes in severity of lymphedema and fibrosis

    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.

    Baseline, 3-, 6-, and 9-months post-intervention

Secondary Outcomes (8)

  • Changes in severity of symptom burden

    Baseline, 3-, 6-, and 9-months post-intervention

  • Changes in degrees of jaw range of motion

    Baseline, 3-, 6-, and 9-months post-intervention

  • Changes in degrees of cervical range of motion

    Baseline, 3-, 6-, and 9-months post-intervention

  • Changes in quality-of-life score

    Baseline, 3-, 6-, and 9-months post-intervention

  • Changes in LEF-related knowledge score

    Baseline, 3-, 6-, and 9-months post-intervention

  • +3 more secondary outcomes

Study Arms (3)

Usual Care

OTHER
Behavioral: Usual Care

In-Person LEF-SMP

EXPERIMENTAL
Behavioral: In-Person LEF-SMP

Telehealth LEF-SMP

EXPERIMENTAL
Behavioral: Telehealth LEF-SMP

Interventions

Usual CareBEHAVIORAL

Participants will conduct self-care activities prescribed by their treating lymphedema therapists.

Usual Care
In-Person LEF-SMPBEHAVIORAL

Participants will receive the in-person LEF-SMP intervention.

In-Person LEF-SMP
Telehealth LEF-SMPBEHAVIORAL

Participants will receive the telehealth LEF-SMP intervention.

Telehealth LEF-SMP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Barbara Murphy

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (1)

  • Deng J, Abene J, Huang L, Murphy BA. Study protocol for a multi-site randomized clinical trial of an intervention program to promote self-management among head and neck cancer survivors with lymphedema and fibrosis [PROMISE trial]. Trials. 2025 Oct 13;26(1):404. doi: 10.1186/s13063-025-09089-x.

    PMID: 41084063DERIVED

MeSH Terms

Conditions

LymphedemaFibrosisHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasms

Central Study Contacts

Jie Deng, PhD

CONTACT

2155732393jiedeng@nursing.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 9, 2023

Study Start

March 29, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)