Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis in China.

NCT05489003 | Unknown DMC

• 1 other identifier: XH20220802
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the status of fatigue, psychological comorbidity and quality of life among patients with chronic pancreatitis in China and analyze their influencing factors.

Conditions

Chronic Pancreatitis

Keywords

Chronic pancreatitis; Fatigue; Anxiety; Depression; Quality of life

Outcome Measures

Primary Outcomes (4)

• The incidence of fatigue among patients with CP in China.

  The level of fatigue in CP patients was measured using the Multidimensional Fatigue Inventory (MFI-20), and the Fatigue Severity Scale (FSS).

  Within 1 month after data analysis.

• The incidence of anxiety among patients with CP in China.

  The level of anxiety in CP patients is measured using the Hospital Anxiety and Depression Scale (HADS), and the Zung Self-Rating Anxiety Scale (SAS).

  Within 1 month after data analysis.

• The incidence of depression among patients with CP in China.

  The level of anxiety in CP patients is measured using the Hospital Anxiety and Depression Scale (HADS), and the Zung Self-rating Depression Scale (SDS).

  Within 1 month after data analysis.

• The incidence of quality of life among patients with CP in China.

  The level of quality of life in CP patients is measured using the European organization for the research and treatment of cancer QOL questionnaire (EORTC-QLQ C-30).

  Within 1 month after data analysis.

Secondary Outcomes (4)

• The influencing factors of fatigue among patients with CP in China.

  Within 1 month after data analysis.

• The influencing factors of anxiety and depression among patients with CP in China.

  Within 1 month after data analysis.

• The influencing factors of depression among patients with CP in China.

  Within 1 month after data analysis.

• The influencing factors of quality of life among patients with CP in China.

  Within 1 month after data analysis.

Study Arms (2)

Patients with fatigue

Chronic pancreatitis patients with fatigue measured by professional assessment scales.

Patients without fatigue

Chronic pancreatitis patients without fatigue measured by professional assessment scales.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pancreatitis in China.

You may qualify if:

• Clinical diagnosis of chronic pancreatitis

You may not qualify if:

• Illiterate
• Having communication difficulties
• Unable to complete the questionnaires
• Having a history of psychiatric disorders
• Recent history of psychotropic and sedative drug use
• Pregnancy
• Rejected participants

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic; Fatigue; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Liang-Hao Hu, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang-Hao Hu, MD

CONTACT

+8613817593520; lianghao-hu@smmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: August 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)