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

During the immune checkpoint inhibitor therapy (ICIT), most of the patients stay at home, but there is lacking of the studies to explore their physical and psychological distress, financial toxicity, care needs, and quality of life. Therefore, the aims of this program are to (1) explore the immune-related adverse event (irAE) severity, distress, financial toxicity, and quality of life and examine the psychometric testing of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM); (2) establish the LINE group for assessing irAE severity and change trajectory of quality of life in one-year follow-up and (3) combined retrospective chart review and the finding in aim (2) to develop the risk prediction model in order to identify the high risk population.

NCT Number	NCT06461780
Lead Sponsor	Taipei Veterans General Hospital, Taiwan Collaborators: National Yang Ming Chiao Tung University
Conditions	Cancer, Immunotherapy, IrAE, Distress, Emotional, Care Need, Financial Toxicity, Quality of Life
Enrollment	200 participants
Start Date	2024-03-18
Primary Completion	2028-08-01 (estimated)
Study Completion	2028-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-30