Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06771505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2025-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared with a Validated Quality of Life Questionnaire (SBS QoL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of a new quality of life tool, the SBS disk, in comparison with a quality of life assessment tool, the SBS QoL.', 'timeFrame': 'Day 1', 'description': "Self-questionnaire in the form of a disk which covers 10 themes: Energy, stress level, anxiety, diet, abdominal pain, transit, appliances, social life, social and professional activity, sleep, as well as self-image and intimate life, according to the recommendations of the WHO quality of life assessment.\n\nThese themes are the same as those generally covered by the SBS QoL reference questionnaire, with the exception of self-image and intimacy.\n\nThe themes are evaluated according to the patient's feelings during the past week on a scale from 0 to 10."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Short Bowel syndrome', 'Quality of life'], 'conditions': ['Short Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'Patients with short bowel syndrome have an impact on their quality of life because they need temporary or permanent parenteral nutritional support. The quality of life of these patients has been the subject of several studies and assessment tools exist, such as the Short Bowel Syndrome Quality of Life (SBS QoL). This tool may seem complex and tedious to use in everyday practice. However, it is important to regularly assess the quality of life of these patients. This is why the investigators are proposing to create a new tool for more rapid assessment of the quality of life of patients with short bowel syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will focus on adult patients with short bowel syndrome followed up in the GHS Intensive Clinical Nutrition Department, during a consultation, a day hospital or a conventional hospital stay.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or over\n* Patient able to read and speak French\n* Patient suffering from short bowel syndrome\n\nExclusion Criteria:\n\n* Known cognitive disorders'}, 'identificationModule': {'nctId': 'NCT06771505', 'acronym': 'SBS DISK', 'briefTitle': 'SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared with a Validated Quality of Life Questionnaire (SBS QoL)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared with a Validated Quality of Life Questionnaire (SBS QoL)', 'orgStudyIdInfo': {'id': '69HCL24_0889'}, 'secondaryIdInfos': [{'id': '2024-A02032-45', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Questionnaire completion', 'description': 'The partient completes the two quality of life assessment questionnaires (Short Bowel Syndrome Quality of Life (SBS QoL) and SBS disk assessment tool), in paper format.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'contacts': [{'name': 'Charlotte BERGOIN, Doctor', 'role': 'CONTACT', 'email': 'charlotte.bergoin@chu-lyon.fr', 'phone': '+33 04.78.86.38.69'}, {'name': 'Stéphanie PECORA, Dietitian', 'role': 'CONTACT', 'email': 'stephanie.pecora@chu-lyon.fr', 'phone': '+33 04.78.86.38.69'}, {'name': 'Charlotte BERGOIN, Doctor', 'role': 'CONTACT'}], 'facility': 'Hôpital Lyon Sud - CHLS', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Charlotte BERGOIN, Doctor', 'role': 'CONTACT', 'email': 'charlotte.bergoin@chu-lyon.fr', 'phone': '+33 04.78.86.38.69'}, {'name': 'Stéphanie PECORA, Dietician', 'role': 'CONTACT', 'email': 'stephanie.pecora@chu-lyon.fr', 'phone': '+33 04.78.86.8.69'}], 'overallOfficials': [{'name': 'Charlotte BERGOIN, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'hépato-gastro-entérologie et Assistance nutritionnelle - Hôpital Lyon Sud - CHLS"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}