Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-01 @ 3:24 PM
Study NCT ID:
NCT01181557
Status:
COMPLETED
Last Update Posted:
2010-08-13
First Post:
2010-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Questionnaire to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-12', 'studyFirstSubmitDate': '2010-04-01', 'studyFirstSubmitQcDate': '2010-08-12', 'lastUpdatePostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire number 1, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma', 'timeFrame': 'three month: first admission in hospital preoperative time', 'description': 'Two cohort in preoperative time: first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.'}], 'secondaryOutcomes': [{'measure': 'Questionnaire number 2, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma', 'timeFrame': 'Three months postoperative time', 'description': 'Two cohort in postoperative time (three months after surgical procedure): first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.'}, {'measure': 'Questionnaire number 3, to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma', 'timeFrame': 'Six months after postoperative time', 'description': 'Two cohort in postoperative time (six months after postoperative time): first EORTC QLQ-C30/C38 questionnaire in rectal cancer submitted to RAR and latter in rectal cancer submitted to RARS.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['quality of life'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': "The aim of the present prospective study was to evaluate the prediction accuracy of EORTC QLQ-C30/C38 questionnaire in rectal cancer patient(RC). This study was designed to investigate how the quality of life (QoL) of patients with rectal cancer changes with time after cancer or after stomia.\n\nEligible subjects were consecutively enrolled in the investigators' Institute and subjected to EORTC QLQ-C30/C38 questionnaire.", 'detailedDescription': 'Eligibility criteria: Italian people with adenocarcinoma of rectum. Exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy.\n\nOutcome measures: patient was carried out using a EORTC QLQ-C30/C38 questionnaire.To determine how surgery affects QoL, we divided patients into two groups: first rectal cancer submitted to rectal anterior resection(RAR) and latter rectal cancer submitted to rectal anterior resection with stomia(RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later of after the stoma reconversion in RARS patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to hospital for rectal cancer, Italian resident older than 18 years, without history of psychiatric illness, or preoperative radiotherapy, dived in two cohorts patient with stoma after surgery and patients without stoma after surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rectal cancer\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* History of psychiatric illness\n* Preoperative radiotherapy'}, 'identificationModule': {'nctId': 'NCT01181557', 'briefTitle': 'A Questionnaire to Assess the Quality of Life of Rectal Cancer Patients With or Without Stoma', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}, 'officialTitle': 'Prospective Evaluation of Quality of Life in Patient With Rectal Cancer', 'orgStudyIdInfo': {'id': 'INT-D176768'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'rectal cancer with stoma', 'description': 'rectal cancer submitted to rectal anterior resection with stomia (RARS). Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month after stoma reconversion'}, {'label': 'rectal cancer without stoma', 'description': 'rectal cancer submitted to rectal anterior resection (RAR) Differences in QoL between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later'}, {'label': 'anterior resection of rectum', 'description': 'patients with rectal cancer submitted to RAR and patients with rectal cancer submitted to RARS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20133', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'alberto vannelli, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Alberto Vannelli, Ermanno Leo', 'oldOrganization': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}}}}