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
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 populati...
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doaj-05bc1d2c94424bbeb97d6ef3f5e604432020-11-25T03:04:25ZengBMCBMC Cancer1471-24072020-07-0120111310.1186/s12885-020-07093-9Design 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 trialLidia Delrieu0Amélie Anota1Olivier Trédan2Damien Freyssenet3Aurélia Maire4Brice Canada5Baptiste Fournier6Olivia Febvey-Combes7Frank Pilleul8Amine Bouhamama9Christophe Caux10Florence Joly11Béatrice Fervers12Vincent Pialoux13David Pérol14Olivia Pérol15Department of Cancer and Environment, Léon Bérard Cancer CenterMethodology and Quality of Life in Oncology unit (INSERM UMR 1098), University Hospital of BesançonDepartment of Medical Oncology, Léon Bérard Cancer CenterInter-University Laboratory of Human Movement Biology EA7424, Univ Lyon, University Jean Monnet Saint-EtienneDepartment of Cancer and Environment, Léon Bérard Cancer CenterLaboratory on Vulnerabilities and Innovations in Sport, University Claude Bernard Lyon 1, University of LyonDepartment of Cancer and Environment, Léon Bérard Cancer CenterDepartment of Clinical Research and Innovation, Léon Bérard Cancer CenterDepartment of Interventional Radiology, Léon Bérard Cancer CenterDepartment of Interventional Radiology, Léon Bérard Cancer CenterUniv Lyon, Université Claude Bernard Lyon 1, INSERM 1052, CNRS 5286, Cancer Research Center of Lyon (CRCL), Léon Bérard Cancer CenterMedical Oncology Department, Centre François BaclesseDepartment of Cancer and Environment, Léon Bérard Cancer CenterInter-University Laboratory of Human Movement Biology EA7424, University Claude Bernard Lyon 1, University of LyonDepartment of Clinical Research and Innovation, Léon Bérard Cancer CenterDepartment of Cancer and Environment, Léon Bérard Cancer CenterAbstract 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 .http://link.springer.com/article/10.1186/s12885-020-07093-9Metastatic breast cancerPhysical activityConnected devicesE-healthHealth-related quality of lifeFatigue |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
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 |
spellingShingle |
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 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 BMC Cancer Metastatic breast cancer Physical activity Connected devices E-health Health-related quality of life Fatigue |
author_facet |
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 |
author_sort |
Lidia Delrieu |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
BMC Cancer |
issn |
1471-2407 |
publishDate |
2020-07-01 |
description |
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 . |
topic |
Metastatic breast cancer Physical activity Connected devices E-health Health-related quality of life Fatigue |
url |
http://link.springer.com/article/10.1186/s12885-020-07093-9 |
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