NCT02094495

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 20, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

2.8 years

First QC Date

March 20, 2014

Last Update Submit

June 24, 2014

Conditions

Breast Cancer

Keywords

TamoxifenBreast cancerKnowkedge

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Decision Conflict Scale

    The study outcome measure will be assessed by face-to-face , one time.

Other Outcomes (3)

  • 1. Satisfaction with Decision scale

    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.

  • Female Sexual Function Index - 6 items, Korean version

    The study outcome measure will be assessed by face-to-face, one time.

Study Arms (1)

breast cancer group

Taking tamoxifen

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

breast cancer patients who take tamoxifen at National Cancer Center

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Breast Cancer, National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Eun Sook Lee, MD, PhD

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun Sook Lee, MD, PhD

CONTACT

+82-31-920-2011eslee@ncc.re.kr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Center for Breast Cancer

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 21, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

KR(1)