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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by James Graham Brown Cancer Center
Sponsor:
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT01694225
First received: September 23, 2012
Last updated: May 19, 2014
Last verified: May 2014
  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 of subjects prescription

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:

Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
new to adjuvant hormone treatment
Patients new to adjuvant hormone treatment (< 12 months)
Other: Bubble packaging of subjects prescription
Monthly bubble packaging among women prescribed anti-estrogens
Other Name: anti-estrogen therapy
adjuvant hormonal treatment-intermediate
Patients in intermediate years of adjuvant hormonal treatment (12 - 36 months)
Other: Bubble packaging of subjects prescription
Monthly bubble packaging among women prescribed anti-estrogens
Other Name: anti-estrogen therapy
adjuvant hormonal treatment-late years
Patients in late years of adjuvant hormonal treatment (37 - 60 months)
Other: Bubble packaging of subjects prescription
Monthly bubble packaging among women prescribed anti-estrogens
Other Name: anti-estrogen 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women on anti-estrogen therapy for breast cancer

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694225

Locations
United States, Kentucky
James Graham Brown Cancer Center-University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Elizabeth C Riley, MD    502-562-3429      
Contact: Belma Kantadzic    502-562-3429      
Principal Investigator: Elizabeth C Riley, MD         
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

No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT01694225     History of Changes
Other Study ID Numbers: BCC-BRE-12-Adherence
Study First Received: September 23, 2012
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
Breast cancer
Anti-estrogen therapy

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormone Antagonists
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Estrogen Antagonists
Estrogen Receptor Modulators
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014