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 - Archive ouverte HAL Access content directly
Journal Articles BMC Cancer Year : 2020

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
  • Function : Author
Amélie Anota
  • Function : Author
Olivier Trédan
  • Function : Author
Damien Freyssenet
  • Function : Author
Aurélia Maire
  • Function : Author
Baptiste Fournier
  • Function : Author
Olivia Febvey-Combes
  • Function : Author
Frank Pilleul
  • Function : Author
Amine Bouhamama
  • Function : Author
Christophe Caux
  • Function : Author
Florence Joly
  • Function : Author
Béatrice Fervers
  • Function : Author
Vincent Pialoux
  • Function : Author
David Pérol
  • Function : Author
Olivia Pérol
  • Function : Author

Abstract

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 .

Dates and versions

hal-03869935 , version 1 (24-11-2022)

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Lidia Delrieu, Amélie Anota, Olivier Trédan, Damien Freyssenet, Aurélia Maire, et al.. 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, 2020, 20 (1), pp.622. ⟨10.1186/s12885-020-07093-9⟩. ⟨hal-03869935⟩
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