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

Breast Cancer Clinical Trial

Official title:

Feasibility of Using the GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01239251
• Other study ID #: 10-183
• Status: Terminated
• Phase: N/A
• First received: November 10, 2010
• Last updated: March 4, 2015
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: March 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center 1275 York Avenue	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the usability of the GlowCap system by patients	>60 years of age with early stage breast cancer.	2 years	No
Secondary	Measure the acceptance and satisfaction of the GlowCap reminder system	with respect to medication adherence in patients >60 years with early stage breast cancer taking adjuvant endocrine therapy.	2 years	No

External Links

•   Memorial Sloan Kettering Cancer Center