PHILADELPHIA (September 7, 20201) – A research team led by Penn Nursing’s Jie Deng, PhD, RN, OCN, FAAN, Associate Professor of Nursing in the Department of Biobehavioral Health Sciences, has been approved for a $3 million funding award by the Patient-Centered Outcomes Research Institute (PCORI) to study lymphedema management in head and neck cancer survivors.
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 three-year, multi-site 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 health care utilization between the participants receiving clinic-based versus home-based CDT.
“Treatment decisions for lymphedema occur daily in clinical practice and are consequential to head and neck cancer survivors and their caregivers,” said Deng. “Our study’s results will provide important evidence that is critical to helping patients, caregivers, and relevant stakeholders make informed decisions about lymphedema care.”
The research team works closely with multiple stakeholders including patients, caregivers, health-care providers, health administrations, national organization leaders, and payers to conduct this study.
The study will involve three health systems and will be co-led by Robert Krouse, MD, Professor of Surgery, Perelman School of Medicine at the University of Pennsylvania. The health system sites include the University of Pennsylvania Health System led by Alexander Lin, MD, Associate Professor of Radiation Oncology; Jefferson University Hospitals led by Bryan Spinelli, PT, PhD, Assistant Professor; and Temple University Health System led by Jeffrey Liu, MD, Associate Professor of Otolaryngology.
“This study was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and stakeholders in research, but also for its potential to fill an important evidence gap and give people information to help them better assess their care options,” said PCORI Executive Director Nakela L. Cook, MD, MPH. “We look forward to following the study’s progress and working with Penn Nursing to share the results.”
Penn Nursing’s study was selected for PCORI funding through a highly competitive review process in which patients, clinicians and other stakeholders joined clinical scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage patients and other stakeholders and their methodological rigor among other criteria.
This funding award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. For more information about PCORI’s funding, visit www.pcori.org.
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