Pilot Study About Tamoxifen Therapy for Breast Cancer Pat... | NCT02094495

Studies
Pilot Study About Tamoxifen Therapy for Breast Cancer Patients

NCT02094495

Sponsor

National Cancer Center, Korea

Status

Unknown status

Last Update Posted

Jun 26, 2014Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

South Korea

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

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Mar 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Mar 20, 2014

First Submission Date that Met QC Criteria

Mar 20, 2014

First Posted Date

Mar 21, 2014Estimated

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

Jun 24, 2014

Last Update Posted Date

Jun 26, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eun Sook Lee, Chief, Center for Breast Cancer, National Cancer Center, KoreaPrincipal Investigator

Lead Sponsor

National Cancer Center, KoreaOTHER_GOV

Collaborators

Not provided

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 aim of this study are to to evaluate the knowledge and understanding on tamoxifen theraphy for breast cancer patients and examine the decision conflict scale and satisfaction with decision scale while making decision to take tamoxifen.

Detailed Description

The knowlege questionnaire about tamoxifen was developed by the medication guides that provide for patients taking tamoxifen and hormone therapy for breast cancer fact sheet from National Cancaer Institute. Several experts in the field of breast cancer and gynecologic cancer are going to review and indicate the questionnaire.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

300Estimated

Label	Type	Description	Intervention Names
breast cancer group		Taking tamoxifen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The knowledge questionnaire about tamoxifen	There are no more follow up except one time	The study outcome measure will be assessed by face-to-face, one time.

Secondary Outcomes

Measure	Description	Time Frame
Decision Conflict Scale	There are no more follow up except one time.	The study outcome measure will be assessed by face-to-face , one time.

Other Outcomes

Measure	Description	Time Frame
1. Satisfaction with Decision scale	There are no more follow up except one time	The study outcome measure will be assessed by face-to-face , one time.
Quality of life (EQ-5D, VAS)		The study outcome measure will be assessed by face-to-face, one time.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The breast cancer patients who take tamoxifenExclusion Criteria:

Exclusion criteria

The patients who do not agree to participate in this study
The paitents who have trouble with understanding and reading Korean.

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

breast cancer patients who take tamoxifen at National Cancer Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eun Sook Lee, MD, PhD	Contact	+82-31-920-2011		eslee@ncc.re.kr

Overall Officials

Name	Affiliation	Role
Eun Sook Lee, MD, PhD	National Cancer Center, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Breast Cancer, National Cancer Center	Recruiting	Goyang-si	Gyeonggi-do	410-769	South Korea

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