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Adherence Rate of Monthly Bubble Package Among Patients Prescribed Adjuvant Endocrine Therapy in Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01694225
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Elizabeth Riley, University of Louisville

Brief Summary:
This study aims to establish the feasibility of using a monthly bubble package to improve compliance rates among women prescribed adjuvant endocrine therapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: bubble packaging for monthly prescription Not Applicable

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  (Clinical Trial)
Actual Enrollment : 87 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Estimating the Adherence Rate of a Monthly Bubble Package Among Patients Prescribed Adjuvant Endocrine Therapy in Breast Cancer Survivors
Study Start Date : July 2012
Actual Primary Completion Date : January 28, 2018
Actual Study Completion Date : January 28, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694225


Locations
United States, Kentucky
James Graham Brown Cancer Center-University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
James Graham Brown Cancer Center
Investigators
Principal Investigator: Elizabeth C Riley, MD James Graham Brown Cancer Center- U of Louisville

Responsible Party: Elizabeth Riley, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01694225     History of Changes
Other Study ID Numbers: BCC-BRE-12-Adherence
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan for public sharing of individual participant data

Keywords provided by Elizabeth Riley, University of Louisville:
Breast cancer
Anti-estrogen therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases