This project funded by a National Institutes of Health Award to evaluate methods that reduce psychological distress and immune-related adverse events among cancer survivors receiving immune checkpoint inhibitors (ICIs). This two-part, scalable approach combines an automated telephone symptom management (ATSM) intervention with a targeted telephone-based interpersonal counseling (TIPC) component. The ATSM component is designed to routinely engage patients during immunotherapy to help them recognize, self-manage, and report symptoms. The TIPC supplement is intended for survivors who demonstrate high psychological distress and require additional counseling support. The project addresses the clinical challenge that, while ICIs have produced substantial success across many cancer types, they frequently precipitate symptoms that range from manageable to sentinel indicators of immune-related adverse events. Early recognition and timely communication of such symptoms between patients and clinicians are central to ensuring ongoing, effective cancer treatment and preventing interruptions driven by unaddressed adverse events.
Many symptoms, pain, fatigue, nausea, sleep disturbance, depression and anxiety, may stem from cancer, its treatments, or coexisting conditions, complicating clinical assessment. The interventions under study aim to empower survivors to differentiate which symptoms can be self-managed (hydration, diet adjustments, mild to moderate exercise, managing bowel symptoms) and which warrant clinician attention because they may signal immune-related complications. By offering an automated, easily scalable system to prompt symptom monitoring and provide guidance, the ATSM intervention seeks to normalize reporting and reduce patients' fear that disclosure will automatically lead to cessation of effective cancer therapy. For patients with elevated psychological distress, the addition of telephone-based interpersonal counseling provides a human-delivered support mechanism to address emotional barriers to symptom reporting and self-management.
The project is notable for its broad applicability: it is not limited to a single cancer type and accounts for the variability of medications and combined therapies patients may receive. Sikorskii emphasizes the real-world complexity cancer survivors face-including concurrent chronic conditions that may mimic or worsen treatment-related symptoms, and the importance of creating interventions that work across this heterogeneity. The research tests both efficacy and implementation potential, with an eye toward scalability and integration into routine oncology care. Sikorskii frames the work as a step toward defining when and how to deliver supportive interventions early in treatment and providing additional support throughout the cancer continuum, from diagnosis through long-term survivorship and end-of-life care. The anticipated outcome is a validated, pragmatic pathway that enhances symptom recognition, self-management, and clinician communication, ultimately reducing distress and immune-related adverse events while supporting uninterrupted, planned immunotherapy treatment. Sikorskii highlights that translating these findings to real-world practice will be the next essential step once efficacy and operational feasibility are established.
