Breast Cancer Clinical Trial
Official title:
Utilization of Decision Aids for Tamoxifen Treatment in Breast Cancer Patients: A Randomized Controlled Trial.
NCT number | NCT02488603 |
Other study ID # | NCCKorea |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | June 25, 2015 |
Last updated | July 1, 2015 |
Start date | August 2015 |
Verified date | June 2015 |
Source | National Cancer Center, Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: National Cancer Center |
Study type | Interventional |
This is an educational intervention study for breast cancer patients who undergo tamoxifen treatment. The purpose of the study is to assess the impact of decision aids (DA) on the patients' decision-making process, compliance on drug, and knowledge regarding tamoxifen treatment. Patients will randomly assign to DA group or conventional group. Both groups will have baseline questionnaire surveys before starting tamoxifen treatment, and 4 weeks later follow-up questionnaire surveys.
Status | Not yet recruiting |
Enrollment | 360 |
Est. completion date | |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Breast cancer patients who are recommended to undergo tamoxifen treatment in National Cancer Center, Korea - - Age at least 18 years and more Exclusion Criteria: - Age under 18 years - Inability to read or speak Korean - Disagree to provide a written informed consent |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Cancer Center, Korea |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Knowledge of Tamoxifen Scale | baseline, 4weeks later | No | |
Secondary | Decisional Conflict Scale | Assess the decisional conflict regarding tamoxifen treatment | baseline, 4weeks later | No |
Secondary | Satisfaction with Decision Questionnaire | Assess the satisfaction with decision to undergo tamoxifen treatment | baseline, 4weeks later | No |
Secondary | EORTC QLQ-C30 Questionnaire | Assess the quality of life before and during tamoxfen treatment | baseline, 4weeks later | No |
Secondary | EQ-5D Questionnaire | Assess the quality of life before and during tamoxfen treatment | baseline, 4weeks later | No |
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