Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT03910894
Status:
UNKNOWN
Last Update Posted:
2019-04-12
First Post:
2019-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health-related Quality of Life in Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 376}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2019-03-31', 'studyFirstSubmitQcDate': '2019-04-09', 'lastUpdatePostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related Quality of Life', 'timeFrame': '2012-2016', 'description': 'The EORTC QLQ-C30, a HRQoL questionnaire was used. It consists of 30 items comprising five functional scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain). Six single items are also included (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). The final two items in the questionnaire assess global health and overall QoL. Raw data were transformed to standardized scores ranging from 0 to 100 using the EORTC scoring manual. A high score on the functional scale represents a high level of functioning (i.e., higher is better), whereas a high score on the symptom scale represents a high level of symptoms (i.e., lower is better).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Related Quality of Life']}, 'referencesModule': {'references': [{'pmid': '40495145', 'type': 'DERIVED', 'citation': 'Tiselius C, Johansen F, Rosenblad A, Smedh K. Health-related quality of life is a significant prognostic factor for recurrence and overall survival in patients with colon cancer. BMC Cancer. 2025 Jun 10;25(1):1016. doi: 10.1186/s12885-025-14254-1.'}, {'pmid': '34507560', 'type': 'DERIVED', 'citation': 'Tiselius C, Rosenblad A, Strand E, Smedh K. Risk factors for poor health-related quality of life in patients with colon cancer include stoma and smoking habits. Health Qual Life Outcomes. 2021 Sep 10;19(1):216. doi: 10.1186/s12955-021-01850-5.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates health-related Quality of life in colon cancer patients in Västmanland, Sweden, at diagnosis, at 6 months, 1, 2 and 3 years after diagnosis, measured by the well-validated EORTC QLQ-C30 questionnaire.', 'detailedDescription': 'See above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed with colon cancer in Region Västmanland 2012-2016, that accepted to be included in the study after written consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients diagnosed with colon cancer in Region Västmanland 2012-2016.\n\nExclusion Criteria:\n\nLanguage problems, declined inclusion,'}, 'identificationModule': {'nctId': 'NCT03910894', 'briefTitle': 'Health-related Quality of Life in Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Region Västmanland'}, 'officialTitle': 'Health-related Quality of Life in Colon Cancer Patients', 'orgStudyIdInfo': {'id': 'HRQoL'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Catarina Tiselius, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Västmanland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'On request if suitable.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Västmanland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Catarina Tiselius', 'investigatorAffiliation': 'Region Västmanland'}}}}