Abstract
Introduction
Despite safety and benefits of physical activity during treatment of
localised breast cancer, successful exercise strategies remain to be
determined. The primary objective of the ‘dispositif connecté’, that is,
connected device in English trial is to evaluate the efficacy of two
6-month exercise interventions, either single or combined, concomitant
to adjuvant treatments, on the physical activity level of patients with
breast cancer, compared with usual care: an exercise programme using a
connected device (activity tracker, smartphone application, website) and
a therapeutic patient education intervention. Secondary objectives are
to evaluate adherence to interventions, their impact at 6 and 12 months,
representations and acceptability of interventions, and to assess the
cost-effectiveness of the interventions using quality-adjusted
life-years.
Methods and analysis
This is a 2×2 factorial, multicentre, phase III randomised
controlled trial. The study population (with written informed consent)
will consist of 432 women diagnosed with primary localised invasive
breast carcinoma and eligible for adjuvant chemotherapy, hormonotherapy
and/or radiotherapy. They will be randomly allocated between one of four
arms: (1) web-based connected device (evolving target number of daily
steps and an individualised, semisupervised, adaptive programme of two
walking and one muscle strengthening sessions per week in autonomy), (2)
therapeutic patient education (one educational diagnosis, two collective
educational sessions, one evaluation), (3) combination of both
interventions and (4) control. All participants will receive the
international physical activity recommendations. Assessments (baseline,
6 and 12 months) will include physical fitness tests, anthropometrics
measures, body composition (CT scan, bioelectrical impedance),
self-administered questionnaires (physical activity profile (Recent
Physical Activity Questionnaire), quality of life (European Organization
for Research and Treatment of Cancer Quality-Of-Life Questionnaire-30,
EQ-5D-5L), fatigue (Piper Fatigue Scale-12), social deprivation
(Evaluation of Deprivation and Inequalities in Health Examination
Centres), lifestyle, physical activity barriers, occupational status)
and biological parameters (blood draw).
Ethics and dissemination
This study was reviewed and approved by the French Ethics Committee.
The findings will be disseminated to the scientific and medical
community via publications in peer-reviewed journals and conference
presentations.
Trial registration number
NCT03529383; Pre-results.
Funder
Métropole de Lyon
Fondation
ARC pour la Recherche sur le Cancer
AG2R La
Mondiale
Fondation
pour la Recherche Médicale