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

  • United States
    • 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
Other: 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

University of Louisville

Collaborators

James Graham Brown Cancer Center

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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