The Performance of Patient Support Program in Early Stage... | NCT00769080

Studies
The Performance of Patient Support Program in Early Stage Breast Cancer

NCT00769080

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Nov 29, 2011Estimated

Enrollment

524Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

China

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

Nov 2011

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

Sep 2008

Primary Completion Date

Not provided

Completion Date

Oct 2010Actual

First Submitted Date

Oct 6, 2008

First Submission Date that Met QC Criteria

Oct 7, 2008

First Posted Date

Oct 8, 2008Estimated

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

Nov 28, 2011

Last Update Posted Date

Nov 29, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to compare the 1-year adherence to upfront adjuvant AI for postmenopausal, early stage breast cancer in the two observational arms; Standard Treatment and Standard Treatment plus PSP arm after one year

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

524Actual

Label	Type	Description	Intervention Names
1		Standard Treatment plus PSP
2		Standard Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
compare the 1-year adherence		1 year

Secondary Outcomes

Measure	Description	Time Frame
scores of Beliefs about Medicines Questionnaire (BMQ)		1 year
Scores in Patient Centred Care Questionnaire (PCCQ)		1 year
Morisky scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provide signed and dated written Informed Consent
Have been taking upfront AI adjuvant therapy in line with current SmPC
Be capable of completing drug intake by herself
Be capable of understanding Chinese

Exclusion Criteria:

Upfront adjuvant hormonal therapy by an AI to which upfront adjuvant indication has not been granted by SFDA
Upfront adjuvant AI medication which has exceeded over eight weeks
Previous adjuvant hormonal therapy for breast cancer lasting over 8 weeks other than AI
Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Postmenopausal women with hormone sensitive early breast cancers to whom have been prescribed upfront adjuvant AI medication (aromatase inhibitors; anastrozole or letrozole) according to the current product SmPC. The upfront AI medication must not have exceeded eight weeks.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen Atkin	AstraZeneca	Study Director
Emily Huang	AstraZeneca	Study Chair
Shen Zhenzhou, Prof	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Beijing	Beijing Municipality		China
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22527106	Derived	Yu KD, Zhou Y, Liu GY, Li B, He PQ, Zhang HW, Lou LH, Wang XJ, Wang S, Tang JH, Liu YH, Wang X, Jiang ZF, Ma LW, Gu L, Cao MZ, Zhang QY, Wang SM, Su FX, Zheng H, Li HY, Tang LL, Sun SR, Liu JP, Shao ZM, Shen ZZ. A prospective, multicenter, controlled, observational study to evaluate the efficacy of a patient support program in improving patients' persistence to adjuvant aromatase inhibitor medication for postmenopausal, early stage breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):307-13. doi: 10.1007/s10549-012-2059-8. Epub 2012 Apr 12.

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