Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-04-18 @ 7:48 AM
Study NCT ID:
NCT02094495
Status:
UNKNOWN
Last Update Posted:
2014-06-26
First Post:
2014-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study About Tamoxifen Therapy for Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2014-03-20', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '1. Satisfaction with Decision scale', 'timeFrame': 'The study outcome measure will be assessed by face-to-face , one time.', 'description': 'There are no more follow up except one time'}, {'measure': 'Quality of life (EQ-5D, VAS)', 'timeFrame': 'The study outcome measure will be assessed by face-to-face, one time.'}, {'measure': 'Female Sexual Function Index - 6 items, Korean version', 'timeFrame': 'The study outcome measure will be assessed by face-to-face, one time.'}], 'primaryOutcomes': [{'measure': 'The knowledge questionnaire about tamoxifen', 'timeFrame': 'The study outcome measure will be assessed by face-to-face, one time.', 'description': 'There are no more follow up except one time'}], 'secondaryOutcomes': [{'measure': 'Decision Conflict Scale', 'timeFrame': 'The study outcome measure will be assessed by face-to-face , one time.', 'description': 'There are no more follow up except one time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tamoxifen', 'Breast cancer', 'Knowkedge'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study are to to evaluate the knowledge and understanding on tamoxifen theraphy for breast cancer patients and examine the decision conflict scale and satisfaction with decision scale while making decision to take tamoxifen.', 'detailedDescription': 'The knowlege questionnaire about tamoxifen was developed by the medication guides that provide for patients taking tamoxifen and hormone therapy for breast cancer fact sheet from National Cancaer Institute. Several experts in the field of breast cancer and gynecologic cancer are going to review and indicate the questionnaire.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'breast cancer patients who take tamoxifen at National Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The breast cancer patients who take tamoxifenExclusion Criteria:\n\nExclusion criteria\n\n* The patients who do not agree to participate in this study\n* The paitents who have trouble with understanding and reading Korean.'}, 'identificationModule': {'nctId': 'NCT02094495', 'briefTitle': 'Pilot Study About Tamoxifen Therapy for Breast Cancer Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Pilot Study to Evaluate the Knowledge and Understanding on Tamoxifen Therapy for Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'NCC 2014-0112-0001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'breast cancer group', 'description': 'Taking tamoxifen'}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eun Sook Lee, MD, PhD', 'role': 'CONTACT', 'email': 'eslee@ncc.re.kr', 'phone': '+82-31-920-2011'}, {'name': 'Myong Cheol Lim', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Center for Breast Cancer, National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'centralContacts': [{'name': 'Eun Sook Lee, MD, PhD', 'role': 'CONTACT', 'email': 'eslee@ncc.re.kr', 'phone': '+82-31-920-2011'}], 'overallOfficials': [{'name': 'Eun Sook Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Center for Breast Cancer', 'investigatorFullName': 'Eun Sook Lee', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}