Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors

What this Trial Is About

Researchers are studying cancer survivors who are receiving immune checkpoint inhibitors (ICIs), a treatment that often leads to immune-related side effects affecting about 90% of patients. This study focuses on evaluating symptom self-management strategies to help survivors recognize and report symptoms early, aiming to reduce side effect severity, treatment interruptions, and unscheduled healthcare visits. The trial uses a sequential multiple assignment randomized trial (SMART) design involving survivors within 12 weeks of starting ICIs and experiencing psychological distress. Participants are initially assigned to either an Automated Telephone Symptom Management (ATSM) system or an active control group. ATSM involves weekly phone symptom monitoring using the PRO-CTCAE tool, with symptom summaries sent to healthcare providers and a mailed Handbook offering symptom management advice. Survivors with ongoing distress are then re-randomized to receive additional Telephone Interpersonal Counseling (TIP-C) or continue ATSM alone. TIP-C includes weekly 30-minute counseling calls by a specialist for eight weeks. The active control group receives symptom monitoring without self-management support or counseling. Throughout the 16-week intervention period, participants complete interviews at the start and end of the study and have regular weekly symptom assessments. Researchers collect data on psychological distress, symptom severity, treatment interruptions, and unplanned healthcare visits. The study also analyzes how social support and communication skills impact outcomes. Electronic health records are reviewed for the full participation timeframe to support comprehensive monitoring and evaluation.

Adaptive Symptom Self-Management Immunotherapy Study