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

NCT ID: NCT01239251

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

GlowCap device

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tiffany Traina, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center 1275 York Avenue

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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10-183

Identifier Type: -

Identifier Source: org_study_id

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