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

NCT01239251 | Terminated

• 1 other identifier: 10-183
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

GlowCap; adjuvant endocrine therapy

Outcome Measures

Primary Outcomes (1)

• Assess the usability of the GlowCap system by patients

  \>60 years of age with early stage breast cancer.

  2 years

Secondary Outcomes (1)

• Measure the acceptance and satisfaction of the GlowCap reminder system

  2 years

Study Arms (1)

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

Interventions

GlowCap device 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.

breast cancer patients taking endocrine therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast Cancer Medicine practice outpatients

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking patients

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center 1275 York Avenue

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tiffany Traina, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 11, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (1)