Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:39 PM
Study NCT ID:
NCT01156506
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2010-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focus Group Interviews of Patients With Permanent or Temporary Enterostomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079102', 'term': 'Empowerment'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-11', 'studyFirstSubmitDate': '2010-06-30', 'studyFirstSubmitQcDate': '2010-07-02', 'lastUpdatePostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Educational elements and themes that will optimize rehabilitation and patient education', 'timeFrame': 'up until 10 months from interview', 'description': 'Illumination and discussion of informants´ perspective on rehabilitation and patient education will'}], 'secondaryOutcomes': [{'measure': 'Identification of strategies for improving quality of life', 'timeFrame': 'up until 10 months from interview', 'description': 'Illumination and discussion of informants perspective on the influence of an enterostoma on their lives'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['quality of life', 'patient education', 'rehabilitation', 'focus group interview'], 'conditions': ['Patient Perspective', 'Living With an Enterostoma', 'Mastery', 'Empowerment']}, 'descriptionModule': {'briefSummary': "The study seeks to gain knowledge about new and of alternative ways of organizing ostomy training based on informants' own experiences of life with a stoma.\n\nThe study is designed and conducted as qualitative focus group interviews with three different groups of patients with enterostomas (5-8 in each group): a) people with permanent enterostoma due to cancer, 2) people with permanent enterostoma due to non-cancer and 3) people with a temporary ileostomy.", 'detailedDescription': 'The study is investigating the perspective of the patients who have actually experienced having surgery and living with an enterostoma.\n\nBy applying this method it is possible to gain access and in depth knowledge of complex issues including sensitive data. The dialogue with peers can lead to experiments and associations which might stimulate the informants to produce new insights within the individual and in the group.\n\nThe interviews will be transcribed in full and analyzed with qualitative content analysis with a phenomenological and hermeneutical approach'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Department of surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with permanent enterostoma due to cancer.\n* Patients with permanent enterostoma due to other causes.\n* Patients with temporary ileostomy.\n\nExclusion Criteria:\n\n* Patients with severe mental disorders.\n* Patients who do not communicate in Danish.\n* Patients with severe hearing impairment.'}, 'identificationModule': {'nctId': 'NCT01156506', 'briefTitle': 'Focus Group Interviews of Patients With Permanent or Temporary Enterostomas', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Patient Perspectives on Living With an Enterostoma and Rehabilitation', 'orgStudyIdInfo': {'id': 'AKD02'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anne K. Danielsen, Nurse, MaClN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev University Hospital, department of surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.d.student, RN', 'investigatorFullName': 'Anne Kjærgaard Danielsen', 'investigatorAffiliation': 'Herlev Hospital'}}}}