Association Between Chronic Psychological Stress and Disease Course Outcomes in Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with newly diagnosed or existing pancreatic cancer or other pancreatic diseases who receive care at the Department of Pancreatic Surgery, Zhongshan Hospital Fudan University (Shanghai); the First Affiliated Hospital of Xi'an Jiaotong University (Xi'an); and the Third Xiangya Hospital of Central South University (Changsha). Participants are recruited consecutively from inpatient clinics of these three tertiary hospitals in China.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
320 Participants
are grouped into 2 trial groupsGroup A: High Stress Cohort
Group B: Low Stress Cohort
Trial outcomes
Primary outcomes
1
overall survival
Overall survival (OS) is defined as the duration from the beginning of therapy until death due to any cause.
Time frame
3 yearsSecondary outcomes
1
progression-free-survival
Time from the beginning of therapy to the first progression (PD) in patients with pancreatic cancer
Time frame
3 years2
disease-free-survival
The duration between the date after surgery to the date of any recurrence or death firstly
Time frame
3 years3
The prevalence of depression and/or anxiety among participants as assesed by HADS and PSQI questionnaire
Time frame
3 weeks4
recurrence rate of different types and sites
Time frame
3 yearsOther outcomes
1
The correlation between peripheral stress and inflammatory biomarker and chronic psychological stress scores and the survival outcomes
Peripheral stress and inflammatory biomarker： \- The baseline concentration of peripheral venous blood is collected. The peripheral stress and inflammatory biomarkers include cortisol, ACTH,IL-6,TNF-α and CRP. Chronic psychological stress： - The baseline psychological stress score is assessed using HADS(Anxiety and Depression) and PSQI(Sleep quality) questionnaires. Survival outcomes include: \- Overall survival, Disease free survival, Progression free survival, Negative margin resection rate.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Zhongshan Hospital
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
Source ClinicalTrials.gov