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

Chronic Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489003
• Other study ID #: XH20220802
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Changhai Hospital
• Contact: Liang-Hao Hu, MD
• Phone: +8613817593520
• Email: lianghao-hu[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Chronic pancreatitis (CP) is an inflammatory disease characterized by pancreatic fibrosis. Available studies suggested that the incidence of CP in China was about 13.5 per 100,000 people. Patients with CP often have symptoms of pancreatic endocrine and exocrine insufficiency such as elevated blood sugar, weight loss, muscle loss, combined with complications such as pancreatic duct stones, pancreatic duct stenosis, pancreatic pseudocysts, and have a higher risk of pancreatic cancer, which seriously affects the quality of life of patients.

Psychological comorbidities represented by anxiety and depression were thought to be widespread in CP patients, with available epidemiological studies indicating that the prevalence of anxiety and depression in CP patients in the United States was 36.8% and 46.8%, respectively. In addition, fatigue, as a subjective perception of decreased ability to perform physical and/or intellectual tasks, has also been founded among CP patients.

However, to date, there is a lack of epidemiological studies on fatigue, anxiety, depression and quality of life in Chinese patients with CP. This study will investigate the epidemiological status of fatigue, anxiety, depression, and quality of life in Chinese patients with CP and analyze the factors influencing them.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of chronic pancreatitis

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Fatigue
• Pancreatitis
• Pancreatitis, Chronic

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	The influencing factors of fatigue among patients with CP in China.	Factors included are obtained from the patient's electronic medical record or by asking the patient directly. The content mainly included (1) sociodemographic data: age, gender, education level, income level, marital status, social support level, and patient's life history (smoking and alcohol consumption), etc; (2) clinical data of CP: first symptoms, frequency of abdominal pain, severity of pain, and times of hospitalization for acute pancreatitis, etc; and (3) patient's psychological conditions: the level of anxiety and depression.	Within 1 month after data analysis.
Secondary	The influencing factors of anxiety and depression among patients with CP in China.	Factors included are obtained from the patient's electronic medical record or by asking the patient directly. The content mainly included (1) sociodemographic data: age, gender, education level, income level, marital status, social support level, and patient's life history (smoking and alcohol consumption), etc; (2) clinical data of CP: first symptoms, frequency of abdominal pain, severity of pain, and times of hospitalization for acute pancreatitis, etc.	Within 1 month after data analysis.
Secondary	The influencing factors of depression among patients with CP in China.	Factors included are obtained from the patient's electronic medical record or by asking the patient directly. The content mainly included (1) sociodemographic data: age, gender, education level, income level, marital status, social support level, and patient's life history (smoking and alcohol consumption), etc; (2) clinical data of CP: first symptoms, frequency of abdominal pain, severity of pain, and times of hospitalization for acute pancreatitis, etc.	Within 1 month after data analysis.
Secondary	The influencing factors of quality of life among patients with CP in China.	Factors included are obtained from the patient's electronic medical record or by asking the patient directly. The content mainly included (1) sociodemographic data: age, gender, education level, income level, marital status, social support level, and patient's life history (smoking and alcohol consumption), etc; (2) clinical data of CP: first symptoms, frequency of abdominal pain, severity of pain, and times of hospitalization for acute pancreatitis, etc; and (3) patient's psychological conditions: the level of anxiety and depression.	Within 1 month after data analysis.