Managing symptoms and psychological distress during oral anti-cancer treatment

Michigan State University College of Osteopathic Medicine Department of Psychiatry, received a five-year R01 award through the NCI Community Oncology Research Program to conduct a confirmatory trial titled "Managing symptoms and psychological distress during oral anti-cancer treatment." The study addresses the growing use of FDA-approved oral anti-cancer agents, which reduce time in infusion units but increase patient responsibility for symptom self-management. Many oral agents require long regimens and can carry substantial costs, and reduced clinician contact places survivors at risk for unrecognized or untreated symptoms, fatigue, depression, skin rash and other adverse effects, that drive treatment interruptions and unscheduled health services use such as emergency department or urgent care visits. The project seeks to provide cancer survivors with scalable tools to monitor and manage symptoms, to improve well-being, to reduce treatment interruptions, and to lower costs associated with unscheduled care.

This randomized trial implements an adaptive intervention informed by prior SMART-design R01 studies that established efficacy of symptom self-management strategies and explored optimal intervention sequencing. All participants will receive automated weekly telephone symptom monitoring with summary reports sent to their healthcare providers; this active control condition ensures routine symptom surveillance. The intervention arm adds a symptom self-management guide for survivors; when depressive or anxiety symptoms are elevated, survivors can employ self-management strategies from the guide. If depression or anxiety persists for at least two weeks, the protocol provides an interpersonal counseling intervention. The design aims to confirm the most effective sequence of supports, an adaptive intervention, derived from previous SMART data, optimizing when and for whom self-management or counseling is indicated.

The trial is conducted within NRG Oncology and NCORP frameworks, leveraging a national cooperative group to deliver care-delivery research in diverse community oncology settings where most patients receive treatment. This community-focused approach enhances generalizability and aims to close the gap between evidence-based interventions and routine care delivery. By providing scalable monitoring tools and engaging survivors in self-management, the project targets both clinical outcomes and health system impacts, including potential reductions in emergency department utilization and related costs; the announcement notes that the average emergency department visit cost in Michigan exceeds $1,200, underscoring potential economic benefits of improved symptom control.

The multi-institutional effort with multiple principal investigators and collaborators across the country, including co-PIs Terry Badger and Tracy Crane, and co-investigators from MSU and other institutions. The study builds on a research program that has already demonstrated efficacy and explored sequencing questions; this R01 serves as a confirmatory step toward implementing an evidence-based, scalable adaptive intervention in community oncology. The project also offers research engagement opportunities for students, highlighting prospective research experience as valuable for learning about the state of the science and contributing to impactful care-delivery studies.