A Prospective Cohort Study on the Association Between Chronic Psychological Stress and Disease Course Outcomes in Pancreatic Cancer: A Comprehensive Analysis Based on Multidimensional Dynamic Psychological Assessment (MIND-PANC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 3
- 主要终点
- overall survival
研究概览
简要总结
This is a prospective, observational cohort study (MIND-PANC) to explore the associations of chronic psychological stress with disease progression, treatment outcomes, and prognosis of pancreatic cancer.
Researchers will ask participants to fill out simple questionnaires about their mood, worries, and sleep at the start of the study and at regular follow-up visits. The study will also collect a small blood sample (leftover from routine care) to measure stress-related markers.
Investigators hypothesize that pancreatic cancer patients who have higher levels of ongoing psychological stress (such as anxiety, depression, or poor sleep) tend to have shorter survival times, a higher chance of recurrence, and a poorer response to treatment, compared to patients with lower stress levels.
详细描述
Study Design and Population This is a multicenter, prospective, observational cohort study designed to investigate whether chronic psychological stress (anxiety, depression, and sleep disturbance) is independently associated with disease course outcomes in patients with pancreatic cancer.
Study Procedures At baseline (day 0), participants complete validated self-report instruments: the Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and Pittsburgh Sleep Quality Index (PSQI). Clinical data are extracted from medical records (demographics, tumor stage, CA19-9, treatment history, comorbidities, etc.). A 2 mL remnant peripheral blood sample (collected during routine morning phlebotomy) is obtained for serum separation and storage at -80 °C; samples will be shipped to the central laboratory (Zhongshan Hospital) for batch analysis of biomarkers.
Follow-up assessments occur at key clinical time points (neoadjuvant therapy mid-point, adjuvant therapy mid-point, end of adjuvant therapy, 12-month long-term follow-up, and at disease progression/recurrence). Psychological scales are repeated at each time point. Clinical outcomes (recurrence, progression, treatment modifications, adverse events, survival status) are captured every 3 months via medical records or telephone contact.
Quality Assurance and Data Management
Quality assurance plan: All sites receive standardized training on study procedures, scale administration, and GCP principles. Regular multicenter meetings and annual on-site monitoring/remote auditing by the coordinating center (Fudan University Zhongshan Hospital) are conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Histologically or cytologically confirmed diagnosis of pancreatic cancer, or other pancreatic diseases.
- •Conscious, with basic reading/writing or communication skills, able to understand and complete the questionnaire assessments (either independently, with assistance from research staff, or with help from a family member).
- •Voluntarily agree to participate in this study and sign a written informed consent form.
排除标准
- •Presence of severe cognitive impairment (e.g., dementia, disturbance of consciousness) or a definite history of psychiatric disorders, judged by the investigator as unable to comply with the study assessments, and without a family member who can help complete the questionnaire assessments.
- •Presence of other severe, uncontrolled systemic diseases (e.g., severe heart, lung, or kidney failure), with an estimated life expectancy < 3 months as judged by the investigator.
- •Inability to understand Chinese or presence of severe visual/hearing impairment that affects completion of the questionnaire assessments, and without a family member who can help complete the questionnaire assessments.
研究组 & 干预措施
High Stress Cohort
Pancreatic cancer patients who receive radical resection and exhibit high psychological stress (e.g., defined by a specific cut-off score on the evaluation scale).
Low Stress Cohort
Pancreatic cancer patients who receive radical resection and exhibit low or normal psychological stress
结局指标
主要结局
overall survival
时间窗: 5 years
Overall survival (OS) is defined as the duration from the beginning of therapy until death due to any cause.
次要结局
- Quality of life: the functional status and well-being of patients at baseline(5 years)
- Negative Margin Rate(6 weeks)
- progression-free-survival(5 years)
- disease-free-survival(5 years)