What is the research about?
Lymphedema is the swelling of soft tissues in the body that can progress into the development of hard tissue (fibrosis). This can develop in the head and neck area following head and neck cancer treatment. Lymphedema can substantially impact one’s ability to swallow, limit their ability to move the head and neck, and adds emotional distress due to it altering a person’s physical appearance. The way lymphedema is currently treated is through complete decongestive therapy (CDT), which is done by a certified lymphedema therapist.
Many people with lymphedema are unable to access this specialized therapy in the clinical setting for a variety of reasons, including the potentially high cost of therapy and difficulty finding lymphedema therapy locally. Also, access to clinic-based therapy has been significantly impacted due to the COVID-19 crisis. As such, many people instead use home-based lymphedema therapy techniques. However, no research has been done comparing the effects of clinic-based versus home-based lymphedema therapy.
This study compares two ways to give lymphedema therapy to head and neck cancer survivors who have developed lymphedema after their cancer treatment. It compares the effects of clinic-based and home-based CDT on changes in lymphedema. The study also compares the effects of clinic-based and home-based CDT on the symptoms and physical functional ability of the study participants. In addition, the study compares the healthcare utilization between the participants receiving clinic-based versus home-based CDT.
Who can this research help?
Clinicians, head and neck cancer survivors, caregivers, hospital administrators, and health insurance payers can use findings from this study to learn about ways to manage lymphedema.
What is the research team doing?
The research team plans to enroll 300 adults with head and neck cancer from three comprehensive medical centers. The team is assigning patients by chance to one of two groups with each group having 150 patients in it. One group is clinic-based lymphedema management and one group is home-based lymphedema management. Clinic-based lymphedema management includes a therapist who does the therapy in an outpatient setting twice a week for six weeks. Home-based lymphedema management includes outpatient lymphedema therapy twice a week for two weeks, followed by real-time video-based lymphedema training/consultation two times a week for three weeks, and then one video session and one in-person follow-up with the therapist during week 6. Over 12 months, the team is comparing changes in these patients’ lymphedema, symptoms, physical functional ability, and healthcare utilization.
Patients, caregivers, healthcare providers, health administrators, national organization leaders, and payers help to design and conduct this study.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.