Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-05 @ 3:37 AM
Study NCT ID:
NCT02488603
Status:
UNKNOWN
Last Update Posted:
2015-07-02
First Post:
2015-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decision Aids for Tamoxifen Treatment in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003661', 'term': 'Decision Support Techniques'}, {'id': 'D013629', 'term': 'Tamoxifen'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'lastUpdateSubmitDate': '2015-07-01', 'studyFirstSubmitDate': '2015-06-25', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Knowledge of Tamoxifen Scale', 'timeFrame': 'baseline, 4weeks later'}], 'secondaryOutcomes': [{'measure': 'Decisional Conflict Scale', 'timeFrame': 'baseline, 4weeks later', 'description': 'Assess the decisional conflict regarding tamoxifen treatment'}, {'measure': 'Satisfaction with Decision Questionnaire', 'timeFrame': 'baseline, 4weeks later', 'description': 'Assess the satisfaction with decision to undergo tamoxifen treatment'}, {'measure': 'EORTC QLQ-C30 Questionnaire', 'timeFrame': 'baseline, 4weeks later', 'description': 'Assess the quality of life before and during tamoxfen treatment'}, {'measure': 'EQ-5D Questionnaire', 'timeFrame': 'baseline, 4weeks later', 'description': 'Assess the quality of life before and during tamoxfen treatment'}]}, 'conditionsModule': {'keywords': ['Breast Neoplasms', 'Tamoxifen', 'Decision Aids'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "This is an educational intervention study for breast cancer patients who undergo tamoxifen treatment. The purpose of the study is to assess the impact of decision aids (DA) on the patients' decision-making process, compliance on drug, and knowledge regarding tamoxifen treatment. Patients will randomly assign to DA group or conventional group. Both groups will have baseline questionnaire surveys before starting tamoxifen treatment, and 4 weeks later follow-up questionnaire surveys."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer patients who are recommended to undergo tamoxifen treatment in National Cancer Center, Korea\n* \\- Age at least 18 years and more\n\nExclusion Criteria:\n\n* Age under 18 years\n* Inability to read or speak Korean\n* Disagree to provide a written informed consent'}, 'identificationModule': {'nctId': 'NCT02488603', 'briefTitle': 'Decision Aids for Tamoxifen Treatment in Breast Cancer Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Utilization of Decision Aids for Tamoxifen Treatment in Breast Cancer Patients: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'NCCKorea'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decision aids', 'interventionNames': ['Behavioral: Decision aids (tamoxifen-related educational materials in brochure or mobile app)', 'Drug: tamoxifen']}, {'type': 'NO_INTERVENTION', 'label': 'usual care'}], 'interventions': [{'name': 'Decision aids (tamoxifen-related educational materials in brochure or mobile app)', 'type': 'BEHAVIORAL', 'description': 'Decision aids (tamoxifen-related educational materials in brochure or mobile app)', 'armGroupLabels': ['Decision aids']}, {'name': 'tamoxifen', 'type': 'DRUG', 'armGroupLabels': ['Decision aids']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Eun Sook Lee', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}