Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT06917716
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2025-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Translation and Validation of Chinese COMPAT-SF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 356}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Internal Consistency of COMPAT-SF-CV', 'timeFrame': 'Baseline', 'description': "Internal consistency will be evaluated using Cronbach's alpha for each domain and the total score of the Chinese version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF-CV)."}, {'measure': 'Test-Retest Reliability of COMPAT-SF-CV', 'timeFrame': 'Baseline and 2-week follow-up', 'description': 'Test-retest reliability will be assessed using intraclass correlation coefficient (ICC) between baseline and 2-week follow-up responses on COMPAT-SF-CV.'}, {'measure': 'Construct Validity of COMPAT-SF-CV', 'timeFrame': 'Baseline', 'description': 'Construct validity will be examined through confirmatory factor analysis (CFA) to assess the underlying factor structure of COMPAT-SF-CV.'}, {'measure': 'Criterion Validity of COMPAT-SF-CV', 'timeFrame': 'Baseline', 'description': 'Criterion validity will be assessed by calculating correlations between COMPAT-SF-CV scores and established measures of pain severity, including the Brief Pain Inventory (BPI) and Izbicki pain score.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Pancreatitis', 'Pain Assessment', 'Cross-Cultural Adaptation', 'Comprehensive Pain Assessment Tool Short Form'], 'conditions': ['Chronic Pancreatitis']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to translate, adapt, and test the reliability of a Chinese version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) for people with chronic pancreatitis.\n\nThe study will answer these questions:\n\n* Does the Chinese COMPAT-SF work well to measure pain in people with chronic pancreatitis?\n* Is the Chinese COMPAT-SF accurate and reliable over time?\n\nParticipants will:\n\n* Complete the Chinese COMPAT-SF questionnaire two times, with a 2-week gap.\n* Answer additional pain-related questions using the Brief Pain Inventory (BPI) and the Izbicki Pain Score.\n* Participate in a follow-up to check if the questionnaire gives consistent results over time.\n\nThis study will help make sure that doctors in China have a useful and reliable tool to measure pain in people with chronic pancreatitis.', 'detailedDescription': "This multicenter observational study aims to translate, culturally adapt, and validate the Chinese version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) for individuals with chronic pancreatitis (CP), ensuring it is a reliable and valid pain assessment tool in China.\n\nA total of 356 participants diagnosed with CP will be recruited from Changhai Hospital (Naval Medical University) and Peking Union Medical College Hospital. The study will follow a structured translation process, including forward translation, back translation, expert panel review, and cognitive debriefing to ensure cultural and linguistic appropriateness. Participants will complete the Chinese COMPAT-SF at baseline and again after two weeks to assess test-retest reliability, alongside additional pain assessments using the Brief Pain Inventory (BPI) and Izbicki Pain Score.\n\nPsychometric analysis will evaluate internal consistency (Cronbach's α), test-retest reliability (intraclass correlation coefficient, ICC), construct validity (confirmatory factor analysis, CFA), and criterion validity (correlation with BPI and Izbicki Pain Score). Data will be securely recorded in an electronic database with quality control measures, including predefined range checks, consistency verification, and source data validation against medical records. Standard Operating Procedures (SOPs) will guide participant recruitment, data collection, and statistical analysis, with missing data handled using multiple imputation techniques.\n\nStatistical analyses will include descriptive statistics, Cronbach's α for internal consistency, ICC for reliability, CFA for construct validity, and Pearson correlation to assess criterion validity. This study is expected to provide a scientifically validated, culturally adapted pain assessment tool for chronic pancreatitis, improving clinical evaluation and patient care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will recruit individuals diagnosed with chronic pancreatitis (CP) experiencing pancreatic pain from Changhai Hospital and Peking Union Medical College Hospital. Eligible participants are those who meet the diagnostic criteria outlined in the Guidelines for the Diagnosis and Treatment of Chronic Pancreatitis in China (2018 edition) and have experienced pancreatic pain in the past 12 months. The study will be conducted between March 2025 and June 2026, enrolling participants during their hospital visits.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Diagnosed with chronic pancreatitis (CP) according to the Guidelines for the Diagnosis and Treatment of Chronic Pancreatitis in China (2018 edition). Diagnosis can be confirmed by: •Primary diagnostic criteria: (i) Definitive imaging findings, and (ii) Histopathological confirmation. •Secondary diagnostic criteria: (i) Recurrent upper abdominal pain, (ii) Abnormal serum amylase levels, (iii) Pancreatic exocrine insufficiency, (iv) Pancreatic endocrine insufficiency, (v) Pathogenic gene mutations, and (vi) History of heavy alcohol consumption. •Diagnosis is confirmed if at least one primary criterion or two secondary criteria are met.\n* 2\\. Experience of pancreatic pain in the past 12 months\n\nExclusion Criteria:\n\n* Under 18 years of age.\n* No pancreatic-related pain.\n* Diagnosed with pancreatic cancer or other tumors.\n* Presence of communication or reading impairments.\n* Refusal to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06917716', 'acronym': 'COMPAT-SF-CV', 'briefTitle': 'Translation and Validation of Chinese COMPAT-SF', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Translation and Validation of a Chinese Version of the Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) in Patients With Chronic Pancreatitis', 'orgStudyIdInfo': {'id': 'CHEC2025-050'}}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo-Xiu Ma', 'role': 'CONTACT', 'email': 'maguoxiu@126.com', 'phone': '86-18018598652'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': "Jia-Yun Chen, Master's", 'role': 'CONTACT', 'email': '18221058071@163.com', 'phone': '+86-18221058071'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}