Association of Psychological Distress With Clinical Outcomes in Patients With Digestive System Cancers
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- Xuanwu HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT07924189
- Record updated
- 9 November 2026
- Original description
This prospective observational cohort study aims to investigate the association between psychological distress and clinical outcomes in patients with digestive system cancers, including pancreatic, gastric, and colorectal cancers.Read full original descriptionShow less
Association of Psychological Distress With Clinical Outcomes in Patients With Digestive System Cancers: A Prospective Cohort Study
This prospective observational cohort study aims to investigate the association between psychological distress and clinical outcomes in patients with digestive system cancers, including pancreatic, gastric, and colorectal cancers.
Approximately 100 adult patients who are scheduled to receive first-line systemic anticancer therapy will be enrolled at Xuanwu Hospital, Capital Medical University. Psychological distress will be assessed using the Distress Thermometer (DT), Hospital Anxiety and Depression Scale (HADS), and 12-item General Health Questionnaire (GHQ-12).
Participants will undergo baseline assessments and follow-up evaluations every three months for up to three years. Clinical information, psychological distress scores, laboratory findings, imaging results, and quality-of-life data will be collected.
The primary outcome is progression-free survival (PFS). Secondary outcomes include overall survival (OS), objective response rate (ORR), and quality of life. The study will evaluate whether psychological distress is associated with cancer prognosis after adjusting for potential confounding factors, including cancer stage, treatment regimen, and nutritional status.
As an observational study, no experimental treatment will be assigned, and all participants will receive standard anticancer treatment according to routine clinical practice.
Inclusion: Patients with pathologically confirmed digestive system cancers, including pancreatic cancer, gastric cancer, or colorectal cancer; Male or female patients aged 18 years or older; Patients scheduled to receive first-line systemic anticancer therapy, including chemotherapy, targeted therapy, immunotherapy, or combination therapy, with no systemic treatment for the current cancer lesions within 3 months prior to enrollment; At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Life expectancy of at least 12 weeks, as assessed by the investigator; Willing and able to provide written informed consent to participate in the study.
Exclusion: Presence of acute or chronic psychiatric disorders, or current treatment with antidepressant or anxiolytic medications; Previous treatment in another investigational drug trial; History of another malignancy within the past 3 years or concurrent malignancy; Inability to complete psychological assessment questionnaires due to cognitive impairment, language barriers, or other conditions that interfere with questionnaire completion.