Patients with a metastatic breast cancer suffer from a deteriorated health-related quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program using connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer. ABLE02 is a prospective, national, multicenter, randomized, controlled and open-label study. A total of 244 patients with a metastatic breast cancer, with at least one positive hormone receptor and a first-line chemotherapy planned, will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 h a day during the whole intervention (6 months) with at least three weekly walking sessions and quizzes each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Health-related quality of life will be assessed every 6 weeks and main assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application. An activity program based on a smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors. NCT number: NCT04354233 .

中文翻译：

---

一项全国性、多中心、随机对照试验的设计和方法，用于评估体育活动计划对改善转移性乳腺癌女性健康相关生活质量和减少疲劳的功效：ABLE02 试验。


转移性乳腺癌患者的健康相关生活质量恶化，并出现许多症状，如疼痛、严重疲劳和体能下降。由于身体活动计划的可行性已在该人群中得到证实，ABLE02 旨在评估使用联网设备进行为期 6 个月的身体活动计划的功效，以改善转移性乳腺癌女性的健康相关生活质量并减少疲劳。 ABLE02 是一项前瞻性、全国性、多中心、随机、对照和开放标签研究。总共 244 名转移性乳腺癌患者，至少有一种阳性激素受体并计划进行一线化疗，将被随机分配（1:1 比例）至：(i) 干预组，接受体力活动建议，在整个干预期间（6 个月）每天 24 小时佩戴活动追踪器，每周至少进行三次步行训练，并每周进行有关身体活动和营养的测验 (ii) 控制臂仅接收身体活动建议。每6周评估一次与健康相关的生活质量，主要评估将在基线、M3、M6、M12和M18进行，以评估参与者的临床、物理、生物和心理参数以及生存情况。所有调查问卷都将在专门的应用程序上完成。基于与活动追踪器连接的智能手机应用程序的活动计划可能有助于改善转移性乳腺癌患者的生活质量并减少疲劳。电子医疗的发展提供了获取实时数据以及增强患者权力以改变长期行为的机会。 NCT编号：NCT04354233。