Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT01239251
Status:
TERMINATED
Last Update Posted:
2015-03-06
First Post:
2010-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy
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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2010-11-10', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the usability of the GlowCap system by patients', 'timeFrame': '2 years', 'description': '\\>60 years of age with early stage breast cancer.'}], 'secondaryOutcomes': [{'measure': 'Measure the acceptance and satisfaction of the GlowCap reminder system', 'timeFrame': '2 years', 'description': 'with respect to medication adherence in patients \\>60 years with early stage breast cancer taking adjuvant endocrine therapy.'}]}, 'conditionsModule': {'keywords': ['GlowCap', 'adjuvant endocrine therapy'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the ease of using a new device, called the GlowCap that reminds the patient to take their breast cancer hormone pill. The study will collect information about the experience with this device and what the patient thinks of its role in the daily pill taking routine.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast Cancer Medicine practice outpatients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Early stage breast cancer patients taking adjuvant endocrine therapy (ie, tamoxifen, anastrozole, letrozole, exemestane).\n* Age ≥ 60 years\n* Must have broadband internet access at home (to enable the base for the system to communicate to the Vitality server).\n* Must have a landline or mobile phone\n\nExclusion Criteria:\n\n* Non-English speaking patients'}, 'identificationModule': {'nctId': 'NCT01239251', 'briefTitle': 'GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Feasibility of Using the GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy', 'orgStudyIdInfo': {'id': '10-183'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'breast cancer patients taking endocrine therapy', 'description': 'Breast cancer patients, currently taking adjuvant endocrine therapy will be equipped with a GlowCap device for a period of 30 days. The GlowCap will become part of their medication taking routine.', 'interventionNames': ['Other: GlowCap device']}], 'interventions': [{'name': 'GlowCap device', 'type': 'OTHER', 'description': 'Participants will be provided with a device called the GlowCap for a period of 30 days. The device has visual and auditory cues to help patients remember to take their medication at the same time each day. The GlowCap will be programmed to glow when it is time for each patient to take her medication. The GlowCap will initially glow bright orange for the first hour from the time the patient is scheduled to take the medication. During the second hour, the GlowCap system will play music in addition to continuing to glow. If after 2 hours the patient still has not opened the medication bottle, she will receive a phone call reminding her to take her medication.', 'armGroupLabels': ['breast cancer patients taking endocrine therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center 1275 York Avenue', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Tiffany Traina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}