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GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy

This study has been terminated.
Sponsor:
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

November 10, 2010
November 8, 2011
November 2010
November 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01239251 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy
Feasibility of Using the GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Breast Cancer Medicine practice outpatients

Breast Cancer
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Early stage breast cancer patients taking adjuvant endocrine therapy (ie, tamoxifen, anastrozole, letrozole, exemestane).
  • Age ≥ 60 years
  • Must have broadband internet access at home (to enable the base for the system to communicate to the Vitality server).
  • Must have a landline or mobile phone

Exclusion Criteria:

  • Non-English speaking patients
Female
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01239251
10-183
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Tiffany Traina, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP