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
Lidia Delrieu,
Amélie Anota,
Olivier Trédan,
Damien Freyssenet,
Aurélia Maire,
Brice Canada,
Baptiste Fournier,
Olivia Febvey-Combes,
Frank Pilleul,
Amine Bouhamama,
Christophe Caux,
Florence Joly,
Béatrice Fervers,
Vincent Pialoux,
David Pérol,
Olivia Pérol
Affiliations
Lidia Delrieu
Department of Cancer and Environment, Léon Bérard Cancer Center
Amélie Anota
Methodology and Quality of Life in Oncology unit (INSERM UMR 1098), University Hospital of Besançon
Olivier Trédan
Department of Medical Oncology, Léon Bérard Cancer Center
Damien Freyssenet
Inter-University Laboratory of Human Movement Biology EA7424, Univ Lyon, University Jean Monnet Saint-Etienne
Aurélia Maire
Department of Cancer and Environment, Léon Bérard Cancer Center
Brice Canada
Laboratory on Vulnerabilities and Innovations in Sport, University Claude Bernard Lyon 1, University of Lyon
Baptiste Fournier
Department of Cancer and Environment, Léon Bérard Cancer Center
Olivia Febvey-Combes
Department of Clinical Research and Innovation, Léon Bérard Cancer Center
Frank Pilleul
Department of Interventional Radiology, Léon Bérard Cancer Center
Amine Bouhamama
Department of Interventional Radiology, Léon Bérard Cancer Center
Christophe Caux
Univ Lyon, Université Claude Bernard Lyon 1, INSERM 1052, CNRS 5286, Cancer Research Center of Lyon (CRCL), Léon Bérard Cancer Center
Florence Joly
Medical Oncology Department, Centre François Baclesse
Béatrice Fervers
Department of Cancer and Environment, Léon Bérard Cancer Center
Vincent Pialoux
Inter-University Laboratory of Human Movement Biology EA7424, University Claude Bernard Lyon 1, University of Lyon
David Pérol
Department of Clinical Research and Innovation, Léon Bérard Cancer Center
Olivia Pérol
Department of Cancer and Environment, Léon Bérard Cancer Center
Abstract 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 .
