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

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ClinicalTrials.gov Identifier: NCT01239251
Recruitment Status : Terminated
First Posted : November 11, 2010
Last Update Posted : March 6, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Breast Cancer Other: GlowCap device

Study Design

Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility of Using the GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy
Study Start Date : November 2010
Primary Completion Date : October 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :
  1. Assess the usability of the GlowCap system by patients [ Time Frame: 2 years ]
    >60 years of age with early stage breast cancer.

Secondary Outcome Measures :
  1. Measure the acceptance and satisfaction of the GlowCap reminder system [ Time Frame: 2 years ]
    with respect to medication adherence in patients >60 years with early stage breast cancer taking adjuvant endocrine therapy.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Breast Cancer Medicine practice outpatients

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239251

United States, New York
Memorial Sloan Kettering Cancer Center 1275 York Avenue
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Principal Investigator: Tiffany Traina, MD Memorial Sloan Kettering Cancer Center
More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01239251     History of Changes
Other Study ID Numbers: 10-183
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
adjuvant endocrine therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases