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

NCT07529626 | Not Yet Recruiting

• 1 other identifier: B2026-092R
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pancreatic Tumor, Benign; Pancreatic Cancer, Adult; Pancreatic Cancer Resectable

Keywords

pancreatic cancer; anxiety; depression; psychological distress; Hospital Anxiety and Depression Scale; Pittsburgh Sleep Quality Index; disease progression; Overall survival; quality of life

Outcome Measures

Primary Outcomes (1)

• overall survival

  Overall survival (OS) is defined as the duration from the beginning of therapy until death due to any cause.

  5 years

Secondary Outcomes (4)

• 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

Other Outcomes (1)

• The correlation between peripheral stress and inflammatory biomarker and chronic psychological stress scores and the survival outcomes

  5 years

Study Arms (1)

pancreatic cancer patients who receive radical resection

For patients with pancreatic cancer who receive radical resection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator

Study Sites (3)

the Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

Location

Related Publications (8)

• Peng F, Lu J, Su K, Liu X, Luo H, He B, Wang C, Zhang X, An F, Lv D, Luo Y, Su Q, Jiang T, Deng Z, He B, Xu L, Guo T, Xiang J, Gu C, Wang L, Xu G, Xu Y, Li M, Kelley KW, Cui B, Liu Q. Oncogenic fatty acid oxidation senses circadian disruption in sleep-deficiency-enhanced tumorigenesis. Cell Metab. 2024 Jul 2;36(7):1598-1618.e11. doi: 10.1016/j.cmet.2024.04.018. Epub 2024 May 20.

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• Pariollaud M, Ibrahim LH, Irizarry E, Mello RM, Chan AB, Altman BJ, Shaw RJ, Bollong MJ, Wiseman RL, Lamia KA. Circadian disruption enhances HSF1 signaling and tumorigenesis in Kras-driven lung cancer. Sci Adv. 2022 Sep 30;8(39):eabo1123. doi: 10.1126/sciadv.abo1123. Epub 2022 Sep 28.

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• Peng Z, Song J, Zhu W, Bao H, Hu Y, Shi Y, Cheng X, Jiang M, Fang F, Chen J, Shu X. Impact of sleep deprivation on colon cancer: Unraveling the KynA-P4HA2-HIF-1alpha axis in tumor lipid metabolism and metastasis. Mol Metab. 2025 Mar;93:102109. doi: 10.1016/j.molmet.2025.102109. Epub 2025 Feb 6.

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• Liu JL, Xu X, Rixiati Y, Wang CY, Ni HL, Chen WS, Gong HM, Zhang ZL, Li S, Shen T, Li JM. Dysfunctional circadian clock accelerates cancer metastasis by intestinal microbiota triggering accumulation of myeloid-derived suppressor cells. Cell Metab. 2024 Jun 4;36(6):1320-1334.e9. doi: 10.1016/j.cmet.2024.04.019.

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• Li Y, Yu H, Li ZM, Yin KW, Jin SY, Chen CC, Tan MS, Zhang CJ, Liu XH, Li WP, Yang JM, Zhou AJ, Zhang X, Ni ED, Wang ML, Mo H, Qin C, Hu J, Li SJ, Gao TM, Li JM. Colorectal cancer cells hijack a brain-gut polysynaptic circuit from the lateral septum to enteric neurons to sustain tumor growth. Nat Cancer. 2025 Nov;6(11):1800-1820. doi: 10.1038/s43018-025-01033-x. Epub 2025 Aug 21.

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• Zhou R, Li K, Hu X, Fan S, Gao Y, Xue X, Bu Y, Zhang H, Wang Y, Wei C, Zhang S, Xie Z, Liu C, Chen P, Yin Z, Ren D. Sleep Deprivation Activates a Conserved Lactate-H3K18la-RORalpha Axis Driving Neutrophilic Inflammation Across Species. Adv Sci (Weinh). 2025 Oct;12(38):e04028. doi: 10.1002/advs.202504028. Epub 2025 Jul 21.

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• Cui B, Luo H, He B, Liu X, Lv D, Zhang X, Su K, Zheng S, Lu J, Wang C, Yang Y, Zhao Z, Liu X, Wang X, Zhao Y, Nie X, Jiang Y, Zhang Z, Liu C, Chen X, Cai A, Lv Z, Liu Z, An F, Zhang Y, Yan Q, Kelley KW, Xu G, Xu L, Liu Q, Peng F. Gut dysbiosis conveys psychological stress to activate LRP5/beta-catenin pathway promoting cancer stemness. Signal Transduct Target Ther. 2025 Mar 5;10(1):79. doi: 10.1038/s41392-025-02159-1.

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• Zeng Y, Hu CH, Li YZ, Zhou JS, Wang SX, Liu MD, Qiu ZH, Deng C, Ma F, Xia CF, Liang F, Peng YR, Liang AX, Shi SH, Yao SJ, Liu JQ, Xiao WJ, Lin XQ, Tian XY, Zhang YZ, Tian ZY, Zou JA, Li YS, Xiao CY, Xu T, Zhang XJ, Wang XP, Liu XL, Wu F. Association between pretreatment emotional distress and immune checkpoint inhibitor response in non-small-cell lung cancer. Nat Med. 2024 Jun;30(6):1680-1688. doi: 10.1038/s41591-024-02929-4. Epub 2024 May 13.

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Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic cancer, adult; Anxiety Disorders; Depression; Disease Progression

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 14, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CN (3)