PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program Including a Regular Physical Training, a Medical and Nutritional Follow-up, on Adjuvant Hormonal Treatment Compliance in Breast Cancer Patients Over 70 Years.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Compliance of an adjuvant hormonal therapy
研究概览
简要总结
PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric intervention on treatment compliance, measured regularly by blood dosing of drug metabolites.
Patients in the intervention group will be proposed:
- A regular geriatric follow up including an attentive screening of joint symptoms and functionality,
- An adapted treatment of join pain,
- Weekly sessions of adapted physical activity (Taï Chi),
- And a systematic correction of vitamin D deficits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years old
- •Non metastatic breast cancer, with or without node metastases
- •Hormone Receptor (HR) positive breast cancer patients
- •Women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery or radiotherapy
- •Introduce an hormonal therapy during 5 years
- •Life expectancy > 6 months (at the discretion of the investigator)
- •Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
- •Patient must be available for follow-up
- •Having given written informed consent prior to any procedure related to the study
排除标准
- •No other primary malignant tumor < 5-years old except cured in situ cancer of the cervix, in situ urothelial cancer, or basocellular cancer
- •Patient with an experimental treatment in the 30 days prior to the enrollment
- •Evidence of metastatic disease
- •Not under any administrative or legal supervision
研究组 & 干预措施
A: Interventional adapted physical activity + enhanced geriatr
Geriatric (functionality, gait, nutrition) follow-up, biological tests, anti-aromatase agents blood dosing, clinical assessment. Weekly Taï-Chi exercises.
干预措施: Arm A: adapted physical activity + enhanced geriatric follow-up (Other)
Arm B: control
Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment
干预措施: No intervention (Other)
结局指标
主要结局
Compliance of an adjuvant hormonal therapy
时间窗: 3 years of follow up
Compliance rate is defined as the rate of blood samplings of anti-hormone metabolites in the therapeutic range, within the 7 blood samplings distributed in the 3 years of follow-up
次要结局
- Activities of daily living, functional walking capacity and changes in balance(3 years of follow up)
- Quality of life(3 years of follow up)
- Intensity and duration of musculoskeletal adverse events(3 years of follow up)
- Nutritional status(3 years of follow up)
- Analgesics consumption(3 years of follow up)