Pilot Study About Tamoxifen Therapy for Breast Cancer Patients

June 24, 2014 updated by: Eun Sook Lee, National Cancer Center, Korea

Pilot Study to Evaluate the Knowledge and Understanding on Tamoxifen Therapy for Breast Cancer Patients

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eun Sook Lee, MD, PhD
  • Phone Number: +82-31-920-2011
  • Email: eslee@ncc.re.kr

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Recruiting
        • Center for Breast Cancer, National Cancer Center
        • Contact:
          • Eun Sook Lee, MD, PhD
          • Phone Number: +82-31-920-2011
          • Email: eslee@ncc.re.kr
        • Sub-Investigator:
          • Myong Cheol Lim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

breast cancer patients who take tamoxifen at National Cancer Center

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
breast cancer group
Taking tamoxifen

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Satisfaction with Decision scale
Time Frame: The study outcome measure will be assessed by face-to-face , one time.
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)
Time Frame: The study outcome measure will be assessed by face-to-face, one time.
The study outcome measure will be assessed by face-to-face, one time.
Female Sexual Function Index - 6 items, Korean version
Time Frame: The study outcome measure will be assessed by face-to-face, one time.
The study outcome measure will be assessed by face-to-face, one time.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Eun Sook Lee, MD, PhD, National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC 2014-0112-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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