NCT01694225

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2018

Completed
Last Updated

January 31, 2018

Status Verified

December 1, 2017

Enrollment Period

5.6 years

First QC Date

September 23, 2012

Last Update Submit

January 29, 2018

Conditions

Breast Cancer

Keywords

Breast cancerAnti-estrogen therapy

Study Arms (1)

bubble package for monthly prescription

EXPERIMENTAL

use of bubble packaging for monthly prescription

Other: bubble packaging for monthly prescription

Interventions

bubble packaging for monthly prescriptionOTHER

Monthly bubble packaging among women prescribed anti-estrogens

bubble package for monthly prescription

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Graham Brown Cancer Center-University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elizabeth C Riley, MD

    James Graham Brown Cancer Center- U of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 23, 2012

First Posted

September 27, 2012

Study Start

July 1, 2012

Primary Completion

January 28, 2018

Study Completion

January 28, 2018

Last Updated

January 31, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

no plan for public sharing of individual participant data

Locations

US(1)