June 13 2024
NRG-CC012CD: Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment (SYMON)
NRG Oncology recently activated the NRG-CC012CD clinical study out of the group’s National Cancer Institute (NCI) Community Oncology Research Program (NCORP) research base. There are a vast number of patients who are currently treated with oral anti-cancer agents, and the average cost of receiving or administering these agents is high. The burden of multiple symptoms experienced while taking anti-cancer oral agents has historically been the main driver of treatment interruptions and unscheduled health services use. The way to effectively reduce these risks is through telephone symptom management and monitoring, however, implementation of regular symptom monitoring can be challenging to practices, and patients need support for symptom self-management, especially those who experience depressive and anxiety symptoms.
NRG-CC012CD was designed to address this gap in patient care by testing if weekly automated telephone calls asking patients about their symptoms and reports of these symptoms to practices help lessen symptom burden and visits to the emergency room or urgent care for patients. Patients on oral anti-cancer agents for cancer of any site or stage will be enrolled at 12 community oncology practices. Six practices will be randomized to symptom monitoring only (active control), and 6 practices will be randomized to the adaptive intervention that consists of symptom monitoring plus additional symptom management support for patients. In both arms, patients will receive 15-minute automated telephone calls for 17 weeks about their symptoms, and summary reports of each patient’s symptoms will be sent to practice weekly (symptom monitoring). All practices will have the benefit of having a report of how a patient is doing each week and can take actions as deemed necessary by the practice. In addition, in the adaptive intervention arm, patients will receive a printed symptoms self-management guide with evidence-based strategies for managing symptoms at home. If depressive or anxiety symptoms persist during the first 4 weeks, patients in the intervention arm will receive a telephone interpersonal counseling intervention. The study premise is that providing symptom management tools to patients will lessen the symptom management effort at the practice. As part of study assessments, patients will also receive telephone calls from study staff members with questions regarding symptoms, health concerns, oral anti-cancer medication, health insurance, use of health services, and the financial burden of a patient’s cancer care in the beginning of the study, at 13 weeks, and at 17 weeks. Practice personnel will also be asked via three brief surveys over 2 years of what they think about study interventions, i.e., how symptom monitoring and management fit into practice’s workflow, whether they are feasible, acceptable, and appropriate for implementation at the practice.
“Our main goal is to provide scalable resources to community oncology practices to help monitor patients’ symptoms and engage patients in symptom self-management, both of which are critical for optimal cancer care delivery,” stated Alla Sikorskii, PhD, of Michigan State University and the Principal Investigator of the NRG-CC012CD study.
Following approval of practice’s participation in the study, based on the completed letter of intent, each practice will be notified so they may begin completing all protocol requirements, such as IRB approval and protocol training. At least one practice representative is required to complete the training by attending an in-person training at the semi-annual NRG meeting or a web-based protocol . Once the protocol requirements are fulfilled, practices will be randomized balancing on practice location (urban or serving at least one rural county) and percentage of Spanish speaking patients. Each practice will enroll patients for approximately 2 years for a total of 43 patients per practice.
In addition to the primary objective of determining the impact of the adaptive intervention compared to symptom monitoring only, this study will also be testing if the adaptive intervention improves patient-level outcome of unscheduled health services compared to symptom monitoring only. Exploratory objectives include cost to deliver interventions, patient financial burden, and feasibility, accessibility, and appropriateness of symptom monitoring and management for the practice.
Study documents for the NRG-CC012CD study are available on CTSU.org
More information is available on ClinicalTrials.gov
The NRG-CC012CD patient study webpage is available at www.nrgoncology.org/CC012CD