Dr. Alla Sikorskii will study the management of symptoms and psychological distress during oral anti-cancer treatment
Alla Sikorskii, Ph.D., professor in the Michigan State University College of Osteopathic Medicine (MSUCOM) Department of Psychiatry, has earned a $3,222,560 award to conduct research within the National Cancer Institute (NCI) Community Oncology Research Program (NCORP).
The five-year R01 project, “Managing symptoms and psychological distress during oral anti-cancer treatment,” will provide cancer survivors (people from cancer diagnosis to the end of life) with tools to manage their symptoms, improve their well-being and save costs on unscheduled health services use, such as visits to the emergency department or urgent care.
Mitigating cancer treatment interruptions and high costs of unscheduled health care use
There are currently more than 50 U.S. Food and Drug Administration (FDA)-approved oral anti-cancer agents, and their use is increasing, Dr. Sikorskii said. Many of the newer oral agents have long regimens and can cost $15,000-$100,000 per year. In comparison, a course of traditional infusion chemotherapy for non-small cell lung cancer was estimated at $9,449 with four to six courses per year, she said.
While oral agents mean less time spent in infusion units for people with cancer, they also mean fewer interactions with oncology professionals. People with cancer must self-manage their symptoms (such as fatigue, depression and skin rash) on their own, and these symptoms become the number one driver of treatment interruptions and unscheduled health services use, said Dr. Sikorskii.
“As survivors go through treatment, the ultimate goal is to beat cancer – however, survivors’ well-being during months and years of cancer treatment is very important,” Dr. Sikorskii said. “Managing symptoms can help people stay on treatment and out of the emergency department. Cost for an average emergency department visit in Michigan is over $1,200 and can be higher depending on what needs to be done to address the issue.”
To reduce the risk of these treatment interruptions, symptom monitoring and management are necessary, but are not implemented routinely, she said. Further, psychological distress (such as depressive and anxiety symptoms) can interfere with information processing and motivation, which may affect symptom self-management.
Adaptive intervention for managing symptoms
In this randomized trial, all survivors will receive an automated telephone monitoring of symptoms with weekly summary reports to their health care providers, which is also an active control condition. In the intervention group, the project will provide cancer survivors with a symptom self-management guide. When depressive or anxiety symptoms are elevated, cancer survivors can use self-management strategies from the guide. If depression or anxiety persists for at least two weeks, the survivor will receive interpersonal counseling intervention.
“We are aiming to address the gap between evidence-based and existing care delivery in the community oncology settings,” said Dr. Sikorskii. “This project provides scalable tools for symptom monitoring in oncology settings, and engages people with cancer in symptom self-management, both of which are critical for optimal cancer care delivery.”
“We are aiming to address the gap between evidence-based and existing care delivery in the community oncology settings.”This study builds upon three previous R01s that established the efficacy of the self-management intervention for symptoms. The previous R01 explored optimal sequencing using the innovative sequential multiple assignment randomized trial (SMART) design. This new study is a confirmatory trial of potentially the best sequence of interventions formulated using SMART data, also called an adaptive intervention.
About the award
“MSUCOM is producing world-class research as evidenced by this R01 and other grants,” Dr. Sikorskii said. “This one is unique as it is through a national cooperative group (NRG NCORP) and is currently the only one through NCORP at MSU.”
NRG Oncology’s mission is to improve lives of people with cancer by conducting practice-changing multi-institutional clinical and translational research, according to the website. NRG Oncology has accrued over 6,000 patients for clinical trials and observational studies since March 2014 and currently has 53 actively accruing trials.
NCORP brings cancer clinical trials and care delivery studies to people in their communities, where most people with cancer receive their treatment. This enables key research to be conducted in diverse community settings across a mix of practice models, which in turn, should improve clinical outcomes and survivors’ well-being, Dr. Sikorskii said.
Dr. Sikorskii’s advice to students interested in research is to get engaged in research projects such as this one. “There are things to be learned by reading or doing reviews of what has been already done or pulling retrospective data. However, doing something prospectively and learning about the state of the science as it is relevant to the project has a greater impact both for the student and the project.”
Dr. Sikorskii will lead this project with Terry Badger, Ph.D., RN, PMHCNS-BC, FAPOS, FAAN, of the University of Arizona College of Nursing, and Tracy Crane, Ph.D., RDN, of the University of Miami Department of Medical Oncology, who are multiple principal investigators (MPIs). She also thanks co-investigators from institutions across the country, including co-investigators from MSU, Jennifer Johnson, Ph.D., of the MSU Department of Public Health, and Charles Given, Ph.D., Professor Emeritus in the MSU College of Nursing, and the NRG Cancer Care Delivery Research Committee.