GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy
This study has been terminated.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01239251
First received: November 10, 2010
Last updated: November 8, 2011
Last verified: November 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 10, 2010 | ||||
| Last Updated Date | November 8, 2011 | ||||
| Start Date ICMJE | November 2010 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Assess the usability of the GlowCap system by patients [ Time Frame: 2 years ] [ Designated as safety issue: No ] >60 years of age with early stage breast cancer. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01239251 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Measure the acceptance and satisfaction of the GlowCap reminder system [ Time Frame: 2 years ] [ Designated as safety issue: No ] with respect to medication adherence in patients >60 years with early stage breast cancer taking adjuvant endocrine therapy. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy | ||||
| Official Title ICMJE | Feasibility of Using the GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Breast Cancer Medicine practice outpatients |
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| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Other: GlowCap device
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. |
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| Study Group/Cohort (s) | breast cancer patients taking endocrine therapy
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.
Intervention: Other: GlowCap device |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 8 | ||||
| Estimated Completion Date | November 2012 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01239251 | ||||
| Other Study ID Numbers ICMJE | 10-183 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Memorial Sloan-Kettering Cancer Center | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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