Adherence Rate of Monthly Bubble Package Among Patients P... | NCT01694225

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

NCT01694225

Sponsor

University of Louisville

Status

Completed

Last Update Posted

Jan 31, 2018Actual

Enrollment

87Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

bubble packaging for monthly prescription

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jan 28, 2018Actual

Completion Date

Jan 28, 2018Actual

First Submitted Date

Sep 23, 2012

First Submission Date that Met QC Criteria

Sep 23, 2012

First Posted Date

Sep 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2018

Last Update Posted Date

Jan 31, 2018Actual

Name	Class
James Graham Brown Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bubble package for monthly prescription	Experimental	use of bubble packaging for monthly prescription	Other: bubble packaging for monthly prescription

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bubble packaging for monthly prescription	Other	Monthly bubble packaging among women prescribed anti-estrogens	bubble package for monthly prescription

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth C Riley, MD	James Graham Brown Cancer Center- U of Louisville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
James Graham Brown Cancer Center-University of Louisville		Louisville	Kentucky	40202	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

no plan for public sharing of individual participant data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided