NCT04740697招募中不适用
Pilot Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Rate of patients who adhere to tamoxifen treatment.
研究概览
简要总结
This is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer.
200 patients will be included in the study.
Each patient will be followed for one day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at entry into the study.
- •Patient treated for hormone-dependent localized breast cancer requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
- •Patients treated with tamoxifen for a maximum of 1 to 3 years.
- •Patient affiliated with a Social Security system in France.
- •Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
排除标准
- •Pregnant or breastfeeding women.
- •Any psychological, family, geographical or sociological condition that does not allow the medical follow-up and/or the procedures foreseen in the study protocol to be respected.
- •Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
研究组 & 干预措施
Patient with localized breast cancer.
Other
干预措施: Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen. (Other)
结局指标
主要结局
Rate of patients who adhere to tamoxifen treatment.
时间窗: 18 months after the start of the research
This outcome will be assessed by the completion of the GIRERD questionnaire by the patient.
次要结局
- Plasma concentration of tamoxifen in patients.(18 months after the start of the research)
- Rate of patients taking ACT.(18 months after the start of the research)
- Rate of patients consuming turmeric-based dietary supplements.(18 months after the start of the research)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
2 期
Isotretinoin In Preventing Recurrences In Chronic Recurrent DermatophytosisTineaNCT03471455Post Graduate Institute of Medical Education and Research, Chandigarh100
终止
不适用
Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 DiabetesType 2 DiabetesNCT02130401Scion NeuroStim6
撤回
1 期
A Study to Investigate the Safety and Efficacy of a Novel Furosemide RegimenAcute Decompensated Heart FailureNCT02721511Todd M Koelling, MD
Unknown
不适用
Using ICT to Deliver i-BMI to Promote Smoking Cessation Among Smokers With Chronic DiseasesSmoking CessationNCT03983330The University of Hong Kong60
已完成
不适用
Exploring the feasibility and efficacy of intensive online Cognitive Behavioural Therapy for panic and anxiety: A pilot studyAgoraphobiaMental Health - AnxietyPanic DisorderACTRN12618001501235niversity of New South Wales10