Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-03-09 @ 3:46 PM
Study NCT ID:
NCT05489003
Status:
UNKNOWN
Last Update Posted:
2022-08-16
First Post:
2022-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis in China.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-13', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of fatigue among patients with CP in China.', 'timeFrame': 'Within 1 month after data analysis.', 'description': 'The level of fatigue in CP patients was measured using the Multidimensional Fatigue Inventory (MFI-20), and the Fatigue Severity Scale (FSS).'}, {'measure': 'The incidence of anxiety among patients with CP in China.', 'timeFrame': 'Within 1 month after data analysis.', 'description': '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).'}, {'measure': 'The incidence of depression among patients with CP in China.', 'timeFrame': 'Within 1 month after data analysis.', 'description': '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).'}, {'measure': 'The incidence of quality of life among patients with CP in China.', 'timeFrame': 'Within 1 month after data analysis.', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'The influencing factors of fatigue among patients with CP in China.', 'timeFrame': 'Within 1 month after data analysis.', 'description': "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."}, {'measure': 'The influencing factors of anxiety and depression among patients with CP in China.', 'timeFrame': 'Within 1 month after data analysis.', 'description': "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."}, {'measure': 'The influencing factors of depression among patients with CP in China.', 'timeFrame': 'Within 1 month after data analysis.', 'description': "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."}, {'measure': 'The influencing factors of quality of life among patients with CP in China.', 'timeFrame': 'Within 1 month after data analysis.', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic pancreatitis', 'Fatigue', 'Anxiety', 'Depression', 'Quality of life'], 'conditions': ['Chronic Pancreatitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPsychological 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.\n\nHowever, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic pancreatitis in China.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of chronic pancreatitis\n\nExclusion Criteria:\n\n* Illiterate\n* Having communication difficulties\n* Unable to complete the questionnaires\n* Having a history of psychiatric disorders\n* Recent history of psychotropic and sedative drug use\n* Pregnancy\n* Rejected participants'}, 'identificationModule': {'nctId': 'NCT05489003', 'briefTitle': 'Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis in China.', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis in China.', 'orgStudyIdInfo': {'id': 'XH20220802'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with fatigue', 'description': 'Chronic pancreatitis patients with fatigue measured by professional assessment scales.'}, {'label': 'Patients without fatigue', 'description': 'Chronic pancreatitis patients without fatigue measured by professional assessment scales.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang-Hao Hu', 'role': 'CONTACT', 'email': 'lianghai-hu@smmu.edu.cn', 'phone': '+8613817593520'}, {'name': 'You Zhou, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dan Wang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Liang-Hao Hu, MD', 'role': 'CONTACT', 'email': 'lianghao-hu@smmu.edu.cn', 'phone': '+8613817593520'}], 'overallOfficials': [{'name': 'Liang-Hao Hu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhaoshen Li', 'investigatorAffiliation': 'Changhai Hospital'}}}}