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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment LEF-SMP, Lymphedema and Fibrosis Self-Management Program, for head and neck cancer-related lymphedema?

Research on similar self-management programs for breast cancer-related lymphedema shows that these programs can help reduce symptoms and improve daily living activities. This suggests that the LEF-SMP treatment might also be effective for managing lymphedema in head and neck cancer patients. ^{1 2 3 4 5}

Is the Self-Management Program for Lymphedema safe for humans?

The available research does not provide specific safety data for the Self-Management Program for Lymphedema, but similar self-management programs for lymphedema in other conditions, like breast cancer, have been studied without reported safety concerns. ^{1 2 3 6 7}

How is the LEF-SMP treatment different from other treatments for head and neck cancer-related lymphedema?

The LEF-SMP treatment is unique because it focuses on a self-management program that empowers patients to manage their lymphedema and fibrosis through education and behavior skills, reducing the need for manual lymph drainage and enhancing patient engagement in their own care. ^{1 2 3 8 9}

Eligibility Criteria

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

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

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

My cancer is currently not detectable.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Refinement and Validation of the Head and Neck Lymphedema and Fibrosis Symptom Inventory. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial. [2023]

3. Scotland 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. [2022]

4. Switzerland 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. [2022]

5. United States 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. [2021]

6. Scotland pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of reliability and validity of head and neck external lymphedema and fibrosis assessment criteria. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Validity Testing of the Head and Neck Lymphedema and Fibrosis Symptom Inventory. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Treatment and outcomes of head and neck oedema referrals to a hospital-based lymphoedema service. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility of machine-delivered sequential massage for the management of lymphedema in the head and neck cancer survivor. [2022]