Recruiting

Self-Management

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06125743

Conditions

Lymphedema of the Head and Neck

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Usual Care

In-Person LEF-SMP

Telehealth LEF-SMP

Study Details

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.

Conditions

Lymphedema of the Head and Neck

Study ID

NCT06125743

Start date

Mar 29, 2024

Status verified date

Sep, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Usual Care

experimental: In-Person LEF-SMP

experimental: Telehealth LEF-SMP

Interventions

Usual Care

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

In-Person LEF-SMP

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

Telehealth LEF-SMP

Participants will receive the telehealth LEF-SMP intervention.

Primary outcome measure

  • Changes in severity of lymphedema and fibrosis [ Time Frame: Baseline, 3-, 6-, and 9-months post-intervention ]

Central Contacts and Locations

Central contacts

Jie Deng, PhD

2155732393jiedeng@nursing.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jie Deng, PhD

215-573-2393jiedeng@nursing.upenn.edu

Barbara Murphy

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Lymphedema
  • Fibrosis
  • Head and Neck Cancer
  • Survivorship
  • Self-Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-09-04.