Self-Management Program for Head & Neck Cancer-related Lymphedema

Recruiting at 1 trial location

Overseen By Jie Deng, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Recurrent cancer, Metastatic cancer, Infection, Heart failure, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether the Lymphedema and Fibrosis Self-Management Program (LEF-SMP) can assist individuals with lymphedema (swelling) in the head and neck following cancer treatment. The program aims to reduce symptoms and enhance daily life by teaching self-care routines. Participants will attend in-person sessions, use telehealth services, or receive usual care. The trial seeks head and neck cancer survivors who have completed initial lymphedema therapy but still face challenges in managing the condition due to various barriers. Participants must have internet access and a device like a computer or smartphone. As an unphased trial, this study offers a unique opportunity to explore new ways to manage lymphedema and improve quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this self-management program is safe for head and neck cancer survivors?

Research has shown that the lymphedema and fibrosis self-management program (LEF-SMP) is safe for individuals. Previous studies found that the program reduces symptoms of lymphedema (swelling from fluid buildup) and fibrosis (thickening of tissue) in head and neck cancer survivors. No major side effects were reported. Both the in-person and online versions of the program have been tested and received positive feedback from participants. The program teaches self-care to help manage symptoms and improve quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Self-Management Program for Head & Neck Cancer-related Lymphedema because it offers new, flexible approaches to managing a challenging condition. Unlike standard treatments that often involve regular visits to specialists for manual lymphatic drainage or compression therapy, this program provides patients with the tools to manage their symptoms independently. The program is delivered in two innovative ways: in-person training sessions and telehealth, making it more accessible, especially for those with mobility or travel constraints. By empowering patients to take control of their own care, the program has the potential to improve quality of life and make lymphedema management more sustainable and effective.

What evidence suggests that the LEF-SMP could be effective for managing lymphedema in head and neck cancer survivors?

Research has shown that a self-care program for managing lymphedema and fibrosis (LEF-SMP) can benefit head and neck cancer survivors. A small initial study found that a 6-week LEF-SMP reduced symptoms and improved participants' ability to manage their condition. In this trial, participants will be assigned to either the In-Person LEF-SMP or the Telehealth LEF-SMP. Early results suggest that both in-person and online versions of the program are practical and may offer similar benefits. These findings indicate that LEF-SMP could help reduce the challenges of lymphedema and fibrosis, improving the quality of life for those affected. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have survived head and neck cancer, are currently free of cancer, and have completed initial therapy for lymphedema in the face and neck. Participants must be able to manage their own care, understand English, have internet access with an electronic device at home, and a valid email address.

Inclusion Criteria

I have completed my initial treatment for head and neck cancer.

You need to be able to understand English to answer questions.

My cancer is currently not detectable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either in-person LEF-SMP, telehealth LEF-SMP, or usual care to manage lymphedema and fibrosis

3 months

Regular visits as per intervention type

Follow-up

Participants are monitored for changes in LEF severity, symptom burden, self-efficacy, and quality of life

6 months

Assessments at 3, 6, and 9 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• LEF-SMP

Trial Overview The PROMISE Trial is testing how effective a standardized self-management program (LEF-SMP) is when delivered via telehealth or in-person compared to usual care. It aims to improve self-care for lymphedema and fibrosis among head and neck cancer survivors.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 Intervention

Group II: Telehealth LEF-SMP Experimental Treatment 1 Intervention

Group III: In-Person LEF-SMP Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

The Head and Neck External Lymphedema and Fibrosis (HN-LEF) Assessment Criteria showed high interrater reliability (91% agreement) and intrarater reliability (96.1% agreement) in evaluating lymphedema and fibrosis in 60 head and neck cancer patients, indicating it is a reliable tool for clinicians.

The assessment tool demonstrated good validity by correlating well with ultrasound findings, suggesting it effectively captures soft tissue changes in patients post-cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of reliability and validity of head and neck external lymphedema and fibrosis assessment criteria. Deng, J., Dietrich, MS., Ridner, SH., et al.[2022]

A new patient-reported outcome measure, the Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF Symptom Inventory), was developed and validated to assess symptoms related to lymphedema and fibrosis in head and neck cancer patients, based on a study involving 120 participants.

The initial 64-item survey was shortened to 33 items after feedback indicated it was burdensome, while still effectively capturing important symptom domains, demonstrating good internal consistency for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refinement and Validation of the Head and Neck Lymphedema and Fibrosis Symptom Inventory. Deng, J., Dietrich, MS., Niermann, KJ., et al.[2022]

The self-management lymphedema education program (SMLEP) significantly reduced upper extremity volume and lymphedema-related symptoms in 44 breast cancer patients over a 12-month period, indicating its efficacy in managing lymphedema.

Participants showed improved patient compliance, activities of daily living (ADL), and overall activity levels, suggesting that SMLEP not only helps reduce symptoms but also enhances patients' ability to manage their condition independently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a self-management lymphedema education program on lymphedema, lymphedema-related symptoms, patient compliance, daily living activities and patient activation in patients with breast cancer-related lymphedema: A quasi-experimental study. Cansız, G., Arıkan Dönmez, A., Kapucu, S., et al.[2022]

The Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF SI) was developed to improve early identification and treatment of lymphedema and fibrosis in head and neck cancer patients, demonstrating its importance in patient care.

In a study involving 117 patients, the HN-LEF SI showed strong construct validity, correlating well with established self-report measures, confirming its reliability as a tool for assessing symptoms related to lymphedema and fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity Testing of the Head and Neck Lymphedema and Fibrosis Symptom Inventory. Deng, J., Murphy, BA., Niermann, KJ., et al.[2023]

The Optimal-Lymph-Flow (TOLF) program significantly improved lymphedema symptoms, including the number and severity of symptoms, as well as their impact on daily activities, in breast cancer survivors compared to a control group.

Patients in the TOLF group had a lower incidence of significant arm volume differences (≥5%) at the study's end, indicating better management of lymphedema and suggesting that TOLF could be an effective early intervention in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies in activating lymphatic system to promote lymph flow on lymphedema symptoms in breast cancer survivors: A randomized controlled trial. Du, X., Li, Y., Fu, L., et al.[2022]

The TOLF program, which focuses on self-management strategies, significantly improved lymphedema-related behaviors and symptoms in 41 women with subclinical or mild breast cancer-related lymphedema over a 12-month period.

Most participants (77.5%) maintained their lymphedema status, with 17.5% improving from mild to subclinical lymphedema, indicating that early intervention can effectively prevent progression of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management Strategies for Risk Reduction of Subclinical and Mild Stage of Breast Cancer-Related Lymphedema: A Longitudinal, Quasi-experimental Study. Liu, F., Li, F., Fu, MR., et al.[2021]

Out of 84 head and neck cancer patients, only 35 were able to access home-based lymphedema therapy, primarily due to Medicare denial of coverage, highlighting significant barriers to treatment access.

Among those who received therapy, 97% reported compliance, and 86% experienced symptom improvement, indicating that machine-delivered lymphedema massage is effective in reducing stiffness, pain, and other symptoms associated with lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of machine-delivered sequential massage for the management of lymphedema in the head and neck cancer survivor. Shires, CB., Harris, P., Dewan, K.[2022]

There was a significant increase in head and neck cancer-related lymphoedema (HNCRL) referrals, rising by 251% from 2009 to 2013, with a total of 207 cases assessed during this period.

Self-management strategies, including exercise and compression techniques, proved effective in treating HNCRL, leading to a reduction in average discharge time from 16 months to just 5 months, and decreasing the need for manual lymph drainage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment and outcomes of head and neck oedema referrals to a hospital-based lymphoedema service. Jeffs, E., Huit, M.[2015]

This study aims to evaluate the feasibility and preliminary efficacy of a self-care program for managing lymphedema and fibrosis in head and neck cancer survivors, targeting a sample size of 75 participants over a 12-month period.

The program is designed to improve self-efficacy and adherence to self-care practices, with the expectation that it will lead to reduced symptom burden and functional impairments associated with lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial. Deng, J., Dietrich, MS., Murphy, B.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12519825/

Study protocol for a multi-site randomized clinical trial of an ... Lymphedema and fibrosis (LEF) secondary to head and neck cancer (HNC) treatment is a chronic process and a lifelong commitment to self-care.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06125743

Self-Management for Head and Neck Lymphedema ... 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- ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1368837525004403

Advancing self-management for head and neck cancer ... Deng et al conducted a pilot randomized controlled trial (RCT) evaluating a 6-week Lymphedema and Fibrosis Self-Management Program (LEF-SMP), demonstrating high ...

4. jdc.jefferson.edu jdc.jefferson.edu/cgi/viewcontent.cgi?article=1047&context=ptfp

Feasibility and preliminary efficacy of a lymphedema and ... Feasibility and preliminary efficacy of a lymphedema and fibrosis self-management program for head and neck cancer survivors: a pilot.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40773982/

Feasibility and preliminary efficacy of a lymphedema and ... Feasibility and preliminary efficacy of a lymphedema and fibrosis self-management program for head and neck cancer survivors: a pilot randomized ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0749208125002098

Managing Lymphedema and Fibrosis in Head and Neck ... People who survive head and neck cancer often develop lymphedema and fibrosis (LEF), which can be painful and affect their quality of life.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03030859

Self-Care for Head and Neck Cancer Survivors With ... This randomized pilot clinical trial studies how well the self-care program works in head and neck cancer survivors with lymphedema and fibrosis.