Breast CancerNCT02094495
Pilot Study About Tamoxifen Therapy for Breast Cancer Patients
An observational study of Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: breast cancer patients who take tamoxifen at National Cancer Center
Who may be able to join
- The breast cancer patients who take tamoxifenExclusion Criteria:
Who cannot join
- The patients who do not agree to participate in this study
- The paitents who have trouble with understanding and reading Korean.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Center for Breast Cancer, National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Eun Sook Lee, MD, PhD, +82-31-920-2011, eslee@ncc.re.kr
Myong Cheol Lim
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Tamoxifen, Breast cancer, Knowkedge
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer group | Taking tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The knowledge questionnaire about tamoxifen
There are no more follow up except one time
Measured: The study outcome measure will be assessed by face-to-face, one time.
Secondary outcomes (1)
Decision Conflict Scale
There are no more follow up except one time.
Measured: The study outcome measure will be assessed by face-to-face , one time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eun Sook Lee, National Cancer Center, Korea
- Investigators
- Eun Sook Lee, MD, PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094495
- Sponsor's protocol ID
- NCC 2014-0112-0001
- Status last verified
- Jun 2014
- First submitted
- 20 Mar 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Knowledge and Understanding on Tamoxifen Therapy for Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02094495
- Acronym / sponsor ID
- NCC 2014-0112-0001
- Conditions
- Breast Cancer
- Keywords
- Tamoxifen, Breast cancer, Knowkedge
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jun 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer group | – | –Taking tamoxifen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer patients who take tamoxifen at National Cancer Center
Key inclusion criteria (1 listed)
- The breast cancer patients who take tamoxifenExclusion Criteria:
Key exclusion criteria (2 listed)
- The patients who do not agree to participate in this study
- The paitents who have trouble with understanding and reading Korean.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Decision Conflict Scale
Time frame: The study outcome measure will be assessed by face-to-face , one time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Sook Lee, MD, PhD principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun Sook Lee, MD, PhD (+82-31-920-2011, eslee@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The knowledge questionnaire about tamoxifen (time frame: The study outcome measure will be assessed by face-to-face, one time.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.