Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 7
- 主要终点
- Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period
研究概览
简要总结
This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor (AI). The purpose of the app is to increase adherence to treatment by informing patients about the risks of relapse and adverse event prevention and treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients with histologically verified and radically treated stage II-III hormone receptor positive HER2-negative breast cancer;
- •Age ≥ 18 at the time of initiation of ribociclib therapy;
- •Patients who were prescribed ribociclib + AI (±GnRH agonist for premenopausal men and women) not earlier than 28 days before signing the informed consent;
- •It is allowed to start adjuvant hormone therapy with AI (±GnRH agonist) not earlier than 12 months before the start of ribociclib;
- •Provision of written informed consent.
排除标准
- •Patients participating in any interventional clinical study at the time of signing the informed consent;
- •Patients receiving active treatment for malignant neoplasms other than BC at the time of enrollment.
研究组 & 干预措施
Using Application
HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application
干预措施: Ribociclib (Drug)
Non using Application
HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application
干预措施: Ribociclib (Drug)
Using Application
HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application
干预措施: Letrozole (Drug)
Using Application
HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application
干预措施: Anastrozole (Drug)
Non using Application
HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application
干预措施: Letrozole (Drug)
Non using Application
HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application
干预措施: Anastrozole (Drug)
结局指标
主要结局
Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period
时间窗: 12 months
The difference between the two groups (App and non-App) in number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period (excluding patients who discontinued treatment due to AE, disease relapse, or death)
次要结局
- Number of sessions using the web application per month(Month 1 - Month 36)
- Total duration of sessions (in minutes) per month(Month 1 - Month 36)
- Number of questions to the chatbot per month(Month 1 - Month 36)
- Evaluation of patient satisfaction with the application on a 0-10 visual analog scale (VAS)(Month 1, 3, 6, 12, 24, 36)
- Evaluation of oncologist satisfaction with the application according to a 0-10 VAS(Month 1, 3, 6, 12, 24, 36)
- Number of patients in each response category according to the questionnaire on quality of life(Month 1, 3, 6, 12, 24, 36)
- VAS score according to the questionnaire on quality of life(Month 1, 3, 6, 12, 24, 36)
- Assessment of patient satisfaction with treatment(Month 3, 6, 12, 24, 36)
- Dose intensity(Month 3, 6, 12, 24, 36)
- Number of patients with adverse events (AE)(Month 3, 6, 12, 24, 36)
- Number of patients with dose reduction and/or discontinuation of ribociclib therapy due to progression, death for breast cancer, death from another cause, other AE(Month 3, 6, 12, 24, 36)
- Number of patients by age, education, occupation, TNM (tumor, nodus, metastasis) stage, tumor grade (G), Ki67 level in both app user and non-app user groups(Baseline)