NCT02488603Unknown不适用
Utilization of Decision Aids for Tamoxifen Treatment in Breast Cancer Patients: A Randomized Controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 主要终点
- Change in Knowledge of Tamoxifen Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Breast cancer patients who are recommended to undergo tamoxifen treatment in National Cancer Center, Korea
- •- Age at least 18 years and more
排除标准
- •Age under 18 years
- •Inability to read or speak Korean
- •Disagree to provide a written informed consent
研究组 & 干预措施
Decision aids
Experimental
干预措施: Decision aids (tamoxifen-related educational materials in brochure or mobile app) (Behavioral)
Decision aids
Experimental
干预措施: tamoxifen (Drug)
结局指标
主要结局
Change in Knowledge of Tamoxifen Scale
时间窗: baseline, 4weeks later
次要结局
- Decisional Conflict Scale(baseline, 4weeks later)
- Satisfaction with Decision Questionnaire(baseline, 4weeks later)
- EORTC QLQ-C30 Questionnaire(baseline, 4weeks later)
- EQ-5D Questionnaire(baseline, 4weeks later)
研究者
Eun Sook Lee
MD, PhD
National Cancer Center, Korea
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