Pilot Study About Tamoxifen Therapy for Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02094495
• Other study ID #: NCC 2014-0112-0001
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2014
• Last updated: June 24, 2014
• Start date: June 2014
• Est. completion date: March 2017

Study information

• Verified date: June 2014
• Source: National Cancer Center, Korea
• Contact: Eun Sook Lee, MD, PhD
• Phone: +82-31-920-2011
• Email: eslee[@]ncc.re.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Center for Breast Cancer, National Cancer Center	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	No
Other	Quality of life (EQ-5D, VAS)		The study outcome measure will be assessed by face-to-face, one time.	No
Other	Female Sexual Function Index - 6 items, Korean version		The study outcome measure will be assessed by face-to-face, one time.	No
Primary	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.	No
Secondary	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.	No