Advanced Breast Cancer and Lifestyle Exercise Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Proportion of patients achieving the physical activity program recommendations
研究概览
简要总结
About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer become secondarily metastatic.Thanks to recent therapeutic advances, the median survival ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The physical, biological, psychological and clinical benefits of physical activity (PA) during treatment in patients with localized breast cancer have been widely demonstrated. Numerous studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge, only four interventional studies worldwide focused on the implementation of PA in patients with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA intervention with patients with metastatic breast cancer to see if the observed effects in localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study is an interventional cohort designed to assess the feasibility of a 6-month adapted physical activity intervention, performed under real life conditions in patients with metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •aged 18 to 78 years old,
- •newly diagnosed with a metastatic breast cancer (i.e. within the last 3 months)
- •treated in the CLB by chemotherapy, and/or radiotherapy and/or hormonotherapy and/or targeted therapy.
- •ECOG Performance status <2,
- •being French-speaking
- •able to complete questionnaires and follow instructions in French
- •valid health insurance affiliation.
- •medical certificate of no contraindications to exercise physical activity
排除标准
- •untreated brain metastases
- •uncontrolled cardiac disease,
- •contraindications to PA,
- •unable to be followed for medical, social, familial, geographical or psychological reasons over the study duration,
- •deprivation of liberty by court or administrative decision
- •pregnancy
研究组 & 干预措施
PA intervention
The intervention consisted in a home-based adapted PA program defined at the inclusion, according to patient's capacities.
干预措施: PA intervention (Other)
结局指标
主要结局
Proportion of patients achieving the physical activity program recommendations
时间窗: 6 months
150 min per week of moderate PA assessed by the IPAQ
次要结局
- Variation of oxidative stress(6 months)
- Investigate the effects of a PA intervention on fatigue(6 months)
- Investigate the effects of a PA intervention on fitness level(6 months)
- Investigate the effects of a PA intervention on social deprivation(6 months)
- Investigate the barriers and facilitators of adherence to a PA program(6 months)
- Investigate the effects of a PA intervention on quality of life(6 months)
- Investigate the effects of a PA intervention on changes in anthropometrics(6 months)