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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bubble packaging for monthly prescription
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Anti-estrogen therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • James Graham Brown Cancer Center-University of Louisville

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bubble package for monthly prescription

Arm Description

use of bubble packaging for monthly prescription

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 23, 2012
Last Updated
January 29, 2018
Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01694225
Brief Title
Adherence Rate of Monthly Bubble Package Among Patients Prescribed Adjuvant Endocrine Therapy in Breast Cancer Survivors
Official Title
Estimating the Adherence Rate of a Monthly Bubble Package Among Patients Prescribed Adjuvant Endocrine Therapy in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 28, 2018 (Actual)
Study Completion Date
January 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Anti-estrogen therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bubble package for monthly prescription
Arm Type
Experimental
Arm Description
use of bubble packaging for monthly prescription
Intervention Type
Other
Intervention Name(s)
bubble packaging for monthly prescription
Intervention Description
Monthly bubble packaging among women prescribed anti-estrogens

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth C Riley, MD
Organizational Affiliation
James Graham Brown Cancer Center- U of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
James Graham Brown Cancer Center-University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan for public sharing of individual participant data

Learn more about this trial

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

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