This week the Patient-Centered Outcomes Research Institute (PCORI) announced a $2 million award to the University of Rochester Medical Center to study this topic over the next three years. Principal investigator Supriya Mohile, M.D., M.S., directs the Specialized Oncology Care and Research for the Elderly (SOCARE) clinic at the James P. Wilmot Cancer Center at URMC, and is a co-leader of Wilmot’s Cancer Control and Survivorship Program. She will be working with several collaborators locally and across the country.
Although age is the single most important risk factor for cancer and older people comprise a fast-growing segment of the general population -- ironically no consensus exists among oncologists or geriatricians about the best ways to care for older people when they get cancer. Clinical trials for new cancer therapies traditionally have excluded this group as well, because of co-existing health conditions that naturally develop with aging.
In the PCORI study, Mohile and colleagues will look at the risks of chemotherapy in a new light. They will use a geriatric assessment (GA) survey, a tool available to geriatricians to identify frailty, memory problems, chronic diseases, and other disabilities in patients. However, the majority of oncologists have not adopted GAs into their practices, largely because of a lack of knowledge about how to use the data from GA to inform clinical oncology care.
The study plans to recruit 500 people aged 70 and older with advanced cancer within the University of Rochester Community Clinical Oncology Program. Prior to making a decision about chemotherapy, all patients will take the GA survey. One group will received a summary of the survey results plus targeted interventions for patients and their families to consider. The other group will not get survey results and will receive standard care.
Later, patients and physicians will discuss treatment options. Researchers will audio-record the visit prior to starting chemotherapy, to measure the number of concerns brought up by patients and their families, and how the physician responds. Researchers also will analyze quality of life and satisfaction with care.
Mohile hopes the information from the study will start to fill gaps in knowledge.
“So many issues related to aging are not routinely incorporated into communication about the risks and benefits for chemotherapy,” Mohile said. “We hope the GA survey gives patients a way to report their own health concerns so that a conversation about the risks, safety, and efficacy of chemotherapy can have real meaning and provide a framework for better communication.”
Mohile is part of a national geriatric oncology network (the Cancer and Aging Research Group or CARG) that’s trying to educate thought-leaders in medicine about the need for more research. The message is starting to be heard, she said. At cancer meetings in recent years Mohile has spoken to standing-room-only crowds, as more physicians are realizing they need the data and tools to manage the complex health concerns of aging cancer patients.
PCORI is an independent, non-profit 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.
The URMC study is among 51 projects totaling $88.5 million approved by PCORI’s board of governors on May 6, following a highly competitive review process that included more than 400 applications. All awards in this most recent round of funding were approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
The inclusion of a diverse group of stakeholders and collaborators strengthened the Wilmot award application, Mohile said. For example, Mohile sought input on every aspect of the study from Beverly Canin, a breast cancer survivor and nationally recognized patient advocate. In February Canin was appointed by the National Cancer Institute to serve on a 19-member committee that will review all breast cancer research funded by federal agencies. An Albany-area resident, Canin is active in several New York State cancer groups, and also will lead an advisory board of older patients with cancer and caregivers for Mohile’s research project.
Additional collaborators from the URMC are: Ronald Epstein, M.D., professor of Family Medicine, Psychiatry, Oncology and an expert in doctor-patient communications; Katia Noyes, Ph.D., M.P.H., professor of Surgery and Public Health Sciences, and director of the Surgical Health Outcomes and Research Enterprise (SHORE); David Dougherty, M.D., senior instructor at Wilmot; Gary Morrow, Ph.D., professor of Radiation Oncology and Psychiatry, and director of the UR Cancer Center Community Clinical Oncology Program Research Base (CCOP); Karen Mustian, Ph.D., M.P.H., associate professor of Radiation Oncology; and Charles Heckler, Ph.D., CCOP’s statistician. Outside collaborators are: Arti Hurria, M.D., director of the Cancer and Aging Research Program at City of Hope in Calif., and William Dale, M.D., Ph.D., co-director of the Specialized Oncology Care & Research in the Elderly clinic at the University of Chicago.