Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-09 @ 9:34 PM
Study NCT ID:
NCT02985502
Status:
UNKNOWN
Last Update Posted:
2016-12-07
First Post:
2016-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison of Quality of Life in Patients With Pancreatogenic Diabetes After Pancreatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-06', 'studyFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life Questionnaire', 'timeFrame': '1 day at first appointment'}]}, 'conditionsModule': {'keywords': ['Quality of Life', 'Diabetes Mellitus', 'Pancreatectomy'], 'conditions': ['Quality of Life', 'Diabetes Mellitus', 'Pancreatectomy']}, 'descriptionModule': {'briefSummary': "Background: Pancreatogenic diabetes resulted from total pancreatectomy(TP) is one of the reason why this form of surgery technique is seldom performed. However, with the progress of medical and surgical care nowadays, patients undergone TP could receive better care in endocrine and exocrine insufficiency. In addition, with better understanding of benign pancreatic tumors and pancreatic neuroendocrine tumors, more patients with diffused pancreatic disease are diagnosed; hence, the performance of TP may rise. Nevertheless, the quality of life of patients with pancreatogenic diabetes after TP is still currently controversial.\n\nPurpose: The purpose of this study is to (1) explore the association of fatigue, self-care activities and quality of life in patients with pancreatogenic diabetes after total pancreatectomy; (2) compare the data with diabetic patients after pancreaticoduodenectomy.\n\nMethod: A correlational and comparative cross-sectional approach will be used. The data will be collected with a structured questionnaire via purposive sampling of 120 subjects in an outpatient pancreatic surgical department. Inclusion criteria will be the patients with: (1) age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to participate in the study and sign informed consent. Exclusion criteria will be the patients diagnosed with cancer other than pancreatic cancer and under active treatment. Data will go through propensity score matching and will be analyzed by using descriptive statistics, paired t-test, Chi square test, Pearson's correlation, and conditional logistic regression.\n\nAnticipated achievement: The anticipated achievement of this study is to understand the relationships between fatigue, self-care activities, and quality of life in patients with pancreatogenic diabetes after pancreas surgery. In addition, through this study, the influence of diabetes to patients after pancreatic tumor resection can be explored; and the factors that influence the population's quality of life can be examined. By the filling of this knowledge gap, intervention can be planned accordingly to help improve the population's quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with pancreatogenic diabetes after total pancreatectomy or pancreaticoduodenectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to participate in the study and sign informed consent\n\nExclusion Criteria:\n\n* diagnosed with cancer other than pancreatic cancer and under active treatment'}, 'identificationModule': {'nctId': 'NCT02985502', 'briefTitle': 'The Comparison of Quality of Life in Patients With Pancreatogenic Diabetes After Pancreatectomy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Comparison and Association of Fatigue, Self-care Activities and Quality of Life in Patients With Pancreatogenic Diabetes Mellitus After Total Pancreatectomy or Pancreaticoduodenectomy', 'orgStudyIdInfo': {'id': '201611038RINB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pancreatogenic diabetes', 'description': 'patients with pancreatogenic diabetes after pancreatectomy will be recruited', 'interventionNames': ['Other: pancreatogenic diabetes']}], 'interventions': [{'name': 'pancreatogenic diabetes', 'type': 'OTHER', 'description': 'pancreatogenic diabetes', 'armGroupLabels': ['pancreatogenic diabetes']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsuan-Ju Kuo, MSN', 'role': 'CONTACT', 'email': 'kuo108041@gmail.com', 'phone': '+886929215939'}, {'name': 'Shiow-Ching Shun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hsuan-Ju Kuo, MSN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hsuan-Ju Kuo, MSN', 'role': 'CONTACT', 'email': 'kuo108041@gmail.com', 'phone': '+886-929215939'}, {'name': 'Shiow-Ching Shun, PhD', 'role': 'CONTACT', 'email': 'scshun@ntu.edu.tw', 'phone': '+886-2-23123456', 'phoneExt': '88439'}], 'overallOfficials': [{'name': 'Shiow-Ching Shun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nursing, College of Medicine, National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}