Observational Study on How Chronic Psychological Stress Affects Outcomes in Pancreatic Cancer Patients Using Repeated Psychological Assessments

What this Trial Is About

Researchers are conducting a prospective observational cohort study called MIND-PANC to explore how chronic psychological stress, including anxiety, depression, and sleep problems, may relate to disease progression, treatment results, and prognosis in pancreatic cancer patients. This study aims to understand if higher stress levels are linked to shorter survival, more recurrence, and poorer treatment responses. Participants complete standardized questionnaires at the start and during follow-ups to assess mood, anxiety, depression, and sleep quality. Blood samples leftover from routine care are collected to analyze stress-related biological markers. Follow-up assessments occur at key clinical points such as mid-neoadjuvant therapy, mid-adjuvant therapy, end of adjuvant therapy, one year after treatment, and at disease progression or recurrence. During the study, researchers gather clinical data from medical records and track outcomes like recurrence, progression, treatment changes, adverse events, and survival every three months. Quality assurance involves standardized training, remote and on-site monitoring, and data validation. The main outcome measured is overall survival over three years, with secondary outcomes including progression-free survival, disease-free survival, prevalence of depression or anxiety, and recurrence rates. The study plans to enroll 320 patients aged 18 and older, with participation lasting up to three years.

Association Between Chronic Psychological Stress and Disease Course Outcomes in Pancreatic Cancer