Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT01303393
Status:
COMPLETED
Last Update Posted:
2011-02-24
First Post:
2011-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Information Needs After Surgery for Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-23', 'studyFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'secondaryOutcomes': [{'measure': "Information needs - patients' and next of kins'", 'timeFrame': '7 weeks', 'description': 'In the interviews with patients and next of kins separately they are asked to express their needs for information at that time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patient education. Patient discharge. Needs assessment.'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': "Aim The overall aim was to investigate information needs after surgery for colorectal cancer and factors explaining information needs, both from the patients' perspective and the next of kin's.", 'detailedDescription': 'Sample Inclusion criteria are patients over 18 years of age that have gone through a surgery for colorectal cancer without having a stoma, and their next of kin with whom they live.\n\nInstruments In study I, 100 patients filled in four different instruments 1-2 weeks after discharge to measure: QOL, information needs, sense of coherence and performance status.\n\nQLQ-C30 and QLQ-CR38 were used to measure QOL. INFO26 were used to measure received information. The SOC - Sense of Coherence was used to measure sense of coherence. And finally the scale for ECOG Performance Status was used to measure the level of physical performance status.\n\nIn study II the same patients filled in the same instruments a second time, 5-7 week after discharge.\n\nInformation about marital status, occupation, diagnosis and prognosis were taken from the medical record.\n\nInterviews In study III 16 patients both filled in the instruments in study I and II, and were interviewed to gain a deeper understanding of their information needs. The interviews were semi structured and will be analysed with content analysis.\n\nIn study IV the next of kin to patients in study III were interviewed about their own information needs in connection to discharge.\n\nThe interviews were performed twice for each person, 1-2 weeks after discharge and a second time, 5-7 week after discharge.\n\nData sampling The data were collected consecutively, and every third patient living together with their next of kin were asked to participate in the interviews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion criteria are patients over 18 years of age that have had a surgery for colorectal cancer without having a stoma, and their next of kin with whom they live. They should be able to speak and read Swedish.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult over 18 years of age\n* surgery for colorectal cancer in one of the three hospitals in the study\n* speak and read Swedish\n* be able to understand the instructions written in the questionnaires\n\nExclusion Criteria:\n\n* receiving a stoma\n* don't want to participate\n* not completed at least half of the items in both questionnaires"}, 'identificationModule': {'nctId': 'NCT01303393', 'briefTitle': 'Information Needs After Surgery for Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Information Needs After Surgery for Colorectal Cancer - From the Perspective of the Patient and Next of Kin', 'orgStudyIdInfo': {'id': 'Etics review Dnr 558/2006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery for colorectal cancer', 'description': 'Patients that had surgery for colorectal cancer without receiving a stoma, and their next of kin.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25187', 'city': 'Helsingborg', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Surgical clinic', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'zip': '22185', 'city': 'Lund', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Surgical clinic', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '20502', 'city': 'Malmo', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Surgical clinic', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Maria Lithner, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Surgical clinic, Lund, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Jan Johansson, MD, Associate professor', 'oldOrganization': 'Dpt of Surgery, Lund University, Sweden'}}}}