Exploring Physical and Psychological Distress, Financial Toxicity, Care Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy in One Year Follow-up: Psychometric Testing and Developing Prediction Models for Immune-related Adverse Events

What this Trial Is About

Researchers are studying patients with advanced cancer who are receiving immune checkpoint inhibitor therapy (ICIT) to better understand their physical and psychological distress, financial burden, care needs, and quality of life. The study aims to explore the severity of immune-related adverse events (irAE) and evaluate a tool called the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM). It also seeks to track symptom changes over one year and develop a model to identify patients at high risk of severe side effects. The study includes two parts: a cross-sectional survey to assess distress, financial toxicity, and quality of life in cancer patients receiving ICIT, and a prospective cohort study that follows 200 patients for one year. In the follow-up, patients use a LINE app to report symptoms weekly for the first three months and every three to four weeks thereafter. Questionnaires including CTCAE, Distress Thermometer, financial toxicity scores, care needs, and quality of life assessments are collected at five time points: before treatment and at 3, 6, 9, and 12 months. Participants will complete various questionnaires and symptom reports to help researchers measure symptom severity, distress, financial impact, and care needs throughout their treatment. Data collection happens regularly through the app and scheduled assessments. The study tracks changes in patient-reported outcomes over one year to better understand patient experiences and improve prediction of adverse events during immune therapy.

Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy