Journal Article

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

Maire, Aurélia, Delrieu, Lidia, Freyssenet, Damien, Anota, Amélie, Pialoux, Vincent, Pérol, David, Joly, Florence, Fournier, Baptiste, Pilleul, Frank, Trédan, Olivier, Pérol, Olivia, Bouhamama, Amine, Caux, Christophe, Febvey-Combes, Olivia, Fervers, Béatrice, Canada, Brice

2020

Overview

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 .

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Activity trackers / Adult / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Biomedical and Life Sciences / Biomedicine / Breast cancer / Breast Neoplasms - complications / Breast Neoplasms - mortality / Breast Neoplasms - pathology / Breast Neoplasms - therapy / Cancer / Cancer metastasis / Cancer Research / Cancer therapies / Chemotherapy / Chronic illnesses / Connected devices / Consent / E-health / Epidemiology / Exercise / Exercise Therapy - instrumentation / Exercise Therapy - methods / Fatigue / Fatigue - etiology / Fatigue - psychology / Fatigue - rehabilitation / Feasibility studies / Female / Fitness Trackers / Fractures / Health Promotion and Disease Prevention / Health-related quality of life / Human health and pathology / Humans / Inflammation / Intervention / Life Sciences / Medical informatics / Medical prognosis / Medicine/Public Health / Metastases / Metastasis / Metastatic breast cancer / Methods / Middle Aged / Mobile Applications / Multicenter Studies as Topic / Oncology / Oxidative stress / Patients / Physical activity / Physical fitness / prevention and public health / Progression-Free Survival / Quality of Life / Questionnaires / Randomized Controlled Trials as Topic / Research Design / Santé publique et épidémiologie / Sarcopenia / Sleep / Smartphone / Smartphones / Study Protocol / Surgical Oncology / Surveys and Questionnaires - statistics & numerical data / Tissues and Organs / Womens health