一项全国性、多中心、随机对照临床试验的设计和方法，旨在评估一项身体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轻疲劳的疗效：ABLE02 试验。
Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial.
机构信息
Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.
Inter-University Laboratory of Human Movement Biology EA7424, University Claude Bernard Lyon 1, University of Lyon, Villeurbanne, France.
出版信息
BMC Cancer. 2020 Jul 3;20(1):622. doi: 10.1186/s12885-020-07093-9.
BACKGROUND
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.
METHODS
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.
DISCUSSION
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.
TRIAL REGISTRATION
NCT number: NCT04354233 .
背景
转移性乳腺癌患者的健康相关生活质量恶化，并伴有多种症状，如疼痛、严重疲劳和身体功能下降。由于在该人群中已经证明了身体活动方案的可行性，ABLE02 旨在评估使用连接设备进行 6 个月身体活动方案对改善健康相关生活质量和减轻转移性乳腺癌女性疲劳的疗效。
方法
ABLE02 是一项前瞻性、全国性、多中心、随机、对照和开放标签研究。共有 244 名转移性乳腺癌患者（至少有一个阳性激素受体，计划进行一线化疗）将被随机分配（1:1 比例）至：（i）干预组接受身体活动建议，每天 24 小时佩戴活动追踪器，整个干预期间（6 个月）至少进行三次每周步行锻炼，每周进行一次关于身体活动和营养的测验；（ii）对照组仅接受身体活动建议。每 6 周评估一次健康相关生活质量，主要评估在基线、M3、M6、M12 和 M18 进行，以评估参与者的临床、身体、生物和心理参数及生存情况。所有问卷将在专用应用程序上完成。
讨论
基于与活动追踪器相连的智能手机应用程序的活动方案可能有助于改善转移性乳腺癌患者的生活质量并减轻疲劳。电子健康的发展提供了实时数据的机会，并增强了患者的自主权，以改变长期行为。
试验注册
NCT number：NCT04354233。
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