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Pilot Study About Tamoxifen Therapy for Breast Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Eun Sook Lee, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT02094495
First received: March 20, 2014
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pilot Study to Evaluate the Knowledge and Understanding on Tamoxifen Therapy for Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • The knowledge questionnaire about tamoxifen [ Time Frame: The study outcome measure will be assessed by face-to-face, one time. ] [ Designated as safety issue: No ]
    There are no more follow up except one time


Secondary Outcome Measures:
  • Decision Conflict Scale [ Time Frame: The study outcome measure will be assessed by face-to-face , one time. ] [ Designated as safety issue: No ]
    There are no more follow up except one time.


Other Outcome Measures:
  • 1. Satisfaction with Decision scale [ Time Frame: The study outcome measure will be assessed by face-to-face , one time. ] [ Designated as safety issue: No ]
    There are no more follow up except one time

  • Quality of life (EQ-5D, VAS) [ Time Frame: The study outcome measure will be assessed by face-to-face, one time. ] [ Designated as safety issue: No ]
  • Female Sexual Function Index - 6 items, Korean version [ Time Frame: The study outcome measure will be assessed by face-to-face, one time. ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
breast cancer group
Taking 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

breast cancer patients who take tamoxifen at National Cancer Center

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02094495

Contacts
Contact: Eun Sook Lee, MD, PhD +82-31-920-2011 eslee@ncc.re.kr

Locations
Korea, Republic of
Center for Breast Cancer, National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Eun Sook Lee, MD, PhD    +82-31-920-2011    eslee@ncc.re.kr   
Sub-Investigator: Myong Cheol Lim         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Eun Sook Lee, MD, PhD National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Eun Sook Lee, Chief, Center for Breast Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02094495     History of Changes
Other Study ID Numbers: NCC 2014-0112-0001
Study First Received: March 20, 2014
Last Updated: June 24, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by National Cancer Center, Korea:
Tamoxifen
Breast cancer
Knowkedge

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Tamoxifen
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014