Association Between Chronic Psychological Stress and Disease Course Outcomes in Pancreatic Cancer (MIND-PANC)

June 24, 2026 updated by: Shanghai Zhongshan Hospital

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)

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Data validation: A web-based electronic data capture (EDC) system is used with automated range and logic checks. Queries are generated for out-of-range or inconsistent entries.

Source data verification (SDV): A random sample of 10% of participants will undergo SDV against original medical records. For key endpoints (OS, PFS, and psychological scores), 100% SDV will be performed.

Data dictionary: A comprehensive data dictionary defines all variables, including coding dictionaries (MedDRA for adverse events, WHO Drug Dictionary for concomitant medications).

Standard Operating Procedures (SOPs): SOPs govern recruitment, informed consent, psychological assessment, biospecimen handling, data entry, adverse event reporting, and protocol amendments.

Sample Size Assessment The sample size of 320 patients was calculated based on the primary outcome (OS) using a two-sided alpha of 0.05, power of 80%, a hazard ratio (HR) of 1.5 (high vs. low psychological stress), an event rate of 67.5%, and 10% loss to follow-up. The Schoenfeld formula yields at least 192 death events and 285 completed patients; after accounting for dropouts, 317 patients are needed, rounded to 320. The HR of 1.5 is justified by recent literature and represents a clinically meaningful medium effect size while maintaining feasibility.

Handling of Missing Data For OS, missing survival dates are minimized by active follow-up. For covariates and scale items with random missingness (<15%), multiple imputation (MI) will be used, with complete-case analysis as sensitivity.

Statistical Analysis Plan

Primary analysis: Kaplan-Meier curves, log-rank tests, and multivariable Cox proportional hazards models (adjusting for study center, age, TNM stage, surgery, ECOG score, etc.) will be used to estimate the HR for OS. The proportional hazards assumption will be tested by Schoenfeld residuals.

Secondary analyses: Similar Cox models will be applied to PFS. Longitudinal trajectories of psychological scores (HADS, PHQ-9, GAD-7, PSQI) will be modeled using generalized estimating equations (GEE).

Subgroup and sensitivity analyses: Pre-specified subgroups (by TNM stage, surgery type, age, site) will be examined with interaction tests. Sensitivity analyses will use alternative definitions of psychological stress (e.g., continuous z-score) and different missing data methods.

Bias assessment: E-values will be calculated for unmeasured confounding. Selection bias will be assessed by comparing completers vs. dropouts; worst-case scenario sensitivity analyses will be performed.

Ethics and Dissemination The protocol (version V1.4, dated 20260302) has been approved by the ethics committees of all participating centers. Results will be published in peer-reviewed journals regardless of outcome direction.

Study Type

Observational

Enrollment (Estimated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • The Third Xiangya Hospital Of Central South University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Zhongshan Hospital Affiliated to Fudan University
        • Contact:
    • Shanxi
      • Xi’an, Shanxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiao Tong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 years
Overall survival (OS) is defined as the duration from the beginning of therapy until death due to any cause.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free-survival
Time Frame: 3 years
Time from the beginning of therapy to the first progression (PD) in patients with pancreatic cancer
3 years
disease-free-survival
Time Frame: 3 years
The duration between the date after surgery to the date of any recurrence or death firstly
3 years
The prevalence of depression and/or anxiety among participants as assesed by HADS and PSQI questionnaire
Time Frame: 3 weeks
3 weeks
recurrence rate of different types and sites
Time Frame: 3 years
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between peripheral stress and inflammatory biomarker and chronic psychological stress scores and the survival outcomes
Time Frame: 3 years

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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

First Affiliated Hospital Xi'an Jiaotong University
The Third Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2026-092R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer Resectable

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe