- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01694225
Adherence Rate of Monthly Bubble Package Among Patients Prescribed Adjuvant Endocrine Therapy in Breast Cancer Survivors
January 29, 2018 updated by: Elizabeth Riley, University of Louisville
Estimating the Adherence Rate of a Monthly Bubble Package Among Patients Prescribed Adjuvant Endocrine Therapy in Breast Cancer Survivors
This study aims to establish the feasibility of using a monthly bubble package to improve compliance rates among women prescribed adjuvant endocrine therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study uses Bubble packaging to provide a cost effective way to improve compliance and help direct further interventions to ensure adherence in women on anti-estrogen therapy for breast cancer.
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- James Graham Brown Cancer Center-University of Louisville
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 18 years of age or older
- Estrogen receptor positive (> 1% estrogen expression) by immunohistochemistry
- Invasive breast cancer (stage I, II, III) or DCIS considered for adjuvant endocrine therapy
Exclusion Criteria:
- Patients with metastatic disease (stage IV)
- Patients less than 18 years of age
- Prisoners
- Patients are unable to fill prescriptions at the BCC pharmacy due to insurance limitations or personal preference
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bubble package for monthly prescription
use of bubble packaging for monthly prescription
|
Monthly bubble packaging among women prescribed anti-estrogens
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth C Riley, MD, James Graham Brown Cancer Center- U of Louisville
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
January 28, 2018
Study Completion (Actual)
January 28, 2018
Study Registration Dates
First Submitted
September 23, 2012
First Submitted That Met QC Criteria
September 23, 2012
First Posted (Estimate)
September 27, 2012
Study Record Updates
Last Update Posted (Actual)
January 31, 2018
Last Update Submitted That Met QC Criteria
January 29, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCC-BRE-12-Adherence
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
no plan for public sharing of individual participant data
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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