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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694225
First Posted: September 27, 2012
Last Update Posted: November 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James Graham Brown Cancer Center
  Purpose
This study aims to establish the feasibility of using a monthly bubble package to improve compliance rates among women prescribed adjuvant endocrine therapy.

Condition Intervention
Breast Cancer Other: bubble packaging for monthly prescription

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Enrollment: 87
Study Start Date: July 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
  Contacts and Locations
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
James Graham Brown Cancer Center
Investigators
Principal Investigator: Elizabeth C Riley, MD James Graham Brown Cancer Center- U of Louisville
  More Information

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT01694225     History of Changes
Other Study ID Numbers: BCC-BRE-12-Adherence
First Submitted: September 23, 2012
First Posted: September 27, 2012
Last Update Posted: November 23, 2016
Last Verified: November 2016
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 James Graham Brown Cancer Center:
Breast cancer
Anti-estrogen therapy

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