Connected device and therapeutic patient education to promote physical activity among women with localised breast cancer (DISCO trial): protocol for a multicentre 2×2 factorial randomised controlled trial
Autor: | Marina Touillaud, Tanguy Leroy, Florie Fillol, Olivia Pérol, Elodie Belladame, Jean-Baptiste Fassier, Béatrice Fervers, Marie Préau, Sébastien Pascal, Aurélia Maire, Lionel Perrier, Thierry Durand, Lidia Delrieu, Baptiste Fournier, David Pérol |
---|---|
Přispěvatelé: | Groupe d'analyse et de théorie économique (GATE Lyon Saint-Étienne), Centre National de la Recherche Scientifique (CNRS)-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université Lumière - Lyon 2 (UL2)-École normale supérieure - Lyon (ENS Lyon), Groupe d'Analyse et de Théorie Economique Lyon - Saint-Etienne (GATE Lyon Saint-Étienne), École normale supérieure de Lyon (ENS de Lyon)-Université Lumière - Lyon 2 (UL2)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Centre National de la Recherche Scientifique (CNRS) |
Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
medicine.medical_specialty
Sports medicine Physical fitness Psychological intervention Breast Neoplasms breast tumours law.invention Breast cancer Randomized controlled trial Quality of life Patient Education as Topic Informed consent law medicine Humans Multicenter Studies as Topic Exercise Fatigue Randomized Controlled Trials as Topic sports medicine business.industry General Medicine medicine.disease [SHS.ECO]Humanities and Social Sciences/Economics and Finance Physical activity level MESH: breast tumours medical education & training Clinical Trials Phase III as Topic Physical therapy Quality of Life JEL: I - Health Education and Welfare Medicine Female business |
Zdroj: | BMJ Open BMJ Open, BMJ Publishing Group, 2021, ⟨10.1136/bmjopen-2020-045448⟩ BMJ Open, Vol 11, Iss 9 (2021) BMJ Open, 2021, ⟨10.1136/bmjopen-2020-045448⟩ |
ISSN: | 2044-6055 |
Popis: | 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. |
Databáze: | OpenAIRE |
Externí odkaz: |