A new randomized clinical trial with Dartmouth investigators Kathleen Lyons, ScD, Tor Tosteson, ScD, Zhigang Li, PhD, and collaborators has noted significant improvement in several measures among those who began palliative care early. Their findings are described in, "Early Versus Delayed Initiation of Concurrent Palliative Care Oncology: Patient Outcomes in the ENABLE III Randomized Controlled Trial," published recently in the Journal of Clinical Oncology.
"Survivorship and quality of life are of great interest in clinical cancer research, but can be difficult to evaluate because of high mortality and the need to measure patient-reported outcomes," explained Tosteson, a biostatistician at Dartmouth's Norris Cotton Cancer Center (NCCC). "We developed trial designs and analytic methods that allow the joint estimation and comparison of survival and quality of life data between different treatment strategies. The ENABLE trials have helped to establish the beneficial effects of palliative care on overall survival by interventions targeting patient outcomes."
The team's previous ENABLE II trial established that a carefully designed intervention for patients with late stage cancers improved both quality of life and survival. The recently published ENABLE III study found that an earlier intervention strategy improved survival further.
In this study, investigators researched the outcomes of palliative care which began at the first visit or three months later among 207 patients with late stage cancer. Though the early-entry participants' patient-reported outcomes were not statistically different from the late-entry participants', their one-year survival after enrollment was improved compared to those who entered later. Additionally, outcomes for caregivers were improved.
"Early interventions for caregivers lowered their depression and stress burden in the last month of the patient's life," reported Lyons.
Dartmouth's system of Shared Resources, including the Biostatistics Shared Resource and the Office of Clinical Research, provided key assistance in conducting this trial. The Division of Biostatistics in the Department of Biomedical Sciences at Dartmouth's Geisel School of Medicine contributed faculty expertise to develop new methods for analysis of the trial data. Team science is a priority at Dartmouth, and this study involves a highly cross-disciplinary team from the NCCC Programs of Cancer Control and Cancer Epidemiology.
Looking forward, analyses are underway to identify the mediating factors leading to improved survival and quality of life in both patients and caregivers.
Tosteson is at Dartmouth's Geisel School of Medicine where he is Professor of Community & Family Medicine and of The Dartmouth Institute, and Director of the Division of Biostatistics in the Department of Biomedical Data Science. Lyons is Assistant Professor of Psychiatry at Dartmouth's Geisel School of Medicine. Zhigang Li is Assistant Professor of Data Science and Community and Family Medicine at Geisel. Their work in cancer is facilitated by Dartmouth's Norris Cotton Cancer Center where they are members of the Cancer Control Research Program.
"Early Versus Delayed Initiation of Concurrent Palliative Care Oncology: Patient Outcomes in the ENABLE III Randomized Controlled Trial," was supported by Grants R01NR011871 and R03NR014915 from the National Institute for Nursing Research, P30CA023108 from the National Cancer Institute, UL1 TR001086 from the National Center for Advancing Translational Sciences; by Norris Cotton Cancer Center pilot funding; and by Mentored Research Scholar Grant MRSG 12-113-01-CPPB in Applied and Clinical Research from the American Cancer Society.
About Norris Cotton Cancer Center at Dartmouth-Hitchcock
Norris Cotton Cancer Center combines advanced cancer research at Dartmouth and the Geisel School of Medicine with patient-centered cancer care provided at Dartmouth-Hitchcock Medical Center in Lebanon, NH, at Dartmouth-Hitchcock regional locations in Manchester, Nashua, and Keene, NH, and St. Johnsbury, VT, and at 12 partner hospitals throughout New Hampshire and Vermont. It is one of 41 centers nationwide to earn the National Cancer Institute's "Comprehensive Cancer Center" designation. Learn more about Norris Cotton Cancer Center research, programs, and clinical trials online at cancer.dartmouth.edu.
For more information contact Kirk Cassels at 603-653-6177.