Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Three out of four people who have treatment for head and neck cancer develop lymphedema. Lymphedema is swelling due to the abnormal build-up of lymph fluid in the soft tissue. This swelling can make it hard for people to swallow and move their head and neck. Treatment can help decrease swelling. But many people don’t live near a clinic that offers this treatment. The COVID-19 pandemic has also made it hard for people to get in-person treatment.

In this study, the research team is comparing clinic-based lymphedema treatment with or without home care among people who have had head and neck cancer. Home-based care requires fewer in-clinic visits than clinic-based care. The team wants to learn how well these treatment approaches work to improve patients’ swelling, symptoms, and physical function.

Who can this research help?

Results may help clinic administrators and people who have had head and neck cancer and their doctors when considering ways to treat lymphedema.

What is the research team doing?

The research team is enrolling 300 adult patients with lymphedema at three medical centers in Pennsylvania. Patients have finished treatment for head and neck cancer. All patients in the study are receiving treatment from a certified lymphedema therapist and a compression garment to control swelling. Therapists teach patients about skin care and exercises for their jaw, neck, and shoulders. They also teach patients how to care for their lymphedema on their own at home. All patients have access to an educational website.

The research team is assigning patients by chance to receive treatment at a clinic with or without home care for six weeks. In clinic-based treatment, a therapist provides treatment at the clinic twice a week. In home-based treatment, patients start treatment at the clinic but then have sessions with the therapist at home by video. For the first two weeks, a therapist provides treatment at the clinic twice a week. For the next three weeks, patients have video training sessions with the therapist twice a week at home. In week six, patients have one video session at home and a final session with the therapist at the clinic.

At the start of the study and six weeks, six months, and one year later, the research team is performing physical exams and looking at range of motion in each patient’s jaw and neck. Patients are also answering questions about their symptoms and use of healthcare services.

Patients who have had head and neck cancer, caregivers, clinicians, healthcare administrators, advocacy organizations, and insurers are helping to design and conduct the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 300 adults who have completed treatment for head and neck cancer and who have been diagnosed with head and neck lymphedema
Interventions/
Comparators
  • Clinic-based lymphedema therapy
  • Hybrid (clinic and home-based) lymphedema therapy
Outcomes

Primary: lymphedema severity

Secondary: symptom burden, jaw range of motion, cervical range of motion, healthcare utilization

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 1-year follow-up for primary outcome

Project Information

Jie Deng, PhD, MSN, RN
Robert Krouse, MD
The Trustees of The University of Pennsylvania
$2,999,060
Comparing Two Ways to Manage Lymphedema in Head and Neck Cancer Survivors

Key Dates

July 2021
October 2025
2021

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Funding Opportunity Type
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
Research Priority Area
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: November 30, 2022