2019 ASCO Annual Meeting!
Session: Symptoms and Survivorship
Type: Poster Session
Time: Monday June 3, 1:15 PM to 4:15 PM
Location: Hall A
eMouvoir: Randomized study estimating the impact of a personalized and remote support centered on physical activity (PA) for patients (pts) after breast cancer (BC).
Symptoms and Survivorship
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #322a)
J Clin Oncol 37, 2019 (suppl; abstr TPS11631)
Author(s): Laurence Vanlemmens, Amelie Anota, Emilie Bogart, Virginie Nerich, Didier Cauchois, Alain Dewitte, Etienne Dormeuil, Eric Lartigau, Flora Le Gall, Hervé Mocaer, Aurelie Thenot, Marc-Antoine Brochard, Marie-Cecile Le Deley; Centre Oscar Lambret, Lille, France; Methodology and Quality of Life Unit, Department of Oncology, INSERM UMR 1098, University Hospital of Besancon; French National Platform Quality of Life and Cancer, Besançon, France; Institut Régional Federatif de Cancerologie, Besançon, France; Stimulab, Paris, France; Oscar Lambret Comprehensive Cancer Center, Lille, France
Background: BC pts can reduce their health-related quality of life (HRQoL) encompassing physical, psychological and social components due to cancer and treatments (trts). Despite the strong evidence of the beneficial effects of EPA for BC pts on HRQoL, the cancer pts’ EPA levels most often decline after diagnosis and trts due to physical and psychological components, accessibility to exercise programs, time constraints. Connected watches can now contribute to pts’ deeper commitment to their program by providing reliable trends of their EPA metrics. Notwithstanding this recent progress, cancer pts keep facing challenges to maintain a regular EPA. We aim at evaluating a holistic intervention including a physical activity educator, coaching pts remotely for 4 months (mo), to improve HRQoL after BC. Methods: eMouvoir is a multicenter randomized, controlled phase 3 trial started 4-6 mo after the end of trt among non-metastatic BC pts. It assesses the benefit of a personalized remote EPA coaching, including a connected watch, access to a digital platform, personalized objectives, ≥2 messages per week, weekly lessons, for a 4-mo duration, compared to the standard supportive approach (recommendations for EPA made during visits with the oncologist) in terms of HRQoL. The randomization is balanced 1:1 and controlled for HRQoL at inclusion, trts, exercise practice, age, access to the Internet and center. Main eligibility criteria are: age ≥18; adjuvant or neoadjuvant trt for non-metastatic BC; medical certificate for sports practice. Patients without a connected device are eligible. HRQoL is evaluated using the SF-36 questionnaire, at 4, 8 and 12 mo. Both components (physical and mental summary) at 12 mo are used as co-primary endpoints. The study includes a health-economics evaluation, using EQ-5D and EQ VAS, to estimate the incremental cost-utility ratio. Based on the following assumptions: expected mean difference for each SF-36 component at 12 mo =3 points, standard deviation=15, power=90%, 2-sided alpha=2.5%, 10% drop-outs, 1242 evaluable pts are required, leading to 1380 pts. The trial is funded by the French ministry of health and should open enrollment soon.