ABSTRACT
Background: MoviS: ‘Movement and Health Beyond Care’ is a 3-year randomized controlled trial aiming to educate cancer patients after adjuvant therapy on the benefits of personalized physical activity (PA) and a proper nutritional plan. Methods: In this project, breast cancer (BC) patients who consent to participate will be randomized to Interventional Arm (A), consisting of 3-months of Movis Training, or Control Arm (B), consisting of standard care with no supervised PA. The Movis Training consists of 3-months of aerobic training (2 d/week of supervised training and 1 d/week of unsupervised exercise) with an increase in exercise intensity (40-70% Heart Rate Reserve) and duration (20-60 min). Ad interim analyses every 3-months up to 1-year will be included. The first cohort of eligible BC survivors were enrolled in January 2020 and carried out the Movis Training even during the COVID-19 pandemic. The primary outcome is improvement of Quality of Life (QoL) assessed by European Organization for Research and Treatment of Cancer QoL (EORTC QLQ-C30). The secondary outcomes are improvement of health-related QoL parameters such as: PA level (International Physical Activity Questionnaire;SenseWear Armband), fitness (VO2max), flexibility, strength, psychological well-being (Psychological distress Inventory;Profile of Mood States and diet habit (DianaWeb, MEDIET modified and recall 24h);Anthropometric measurement, Body mass (kg);BMI (kg/m2);body composition. Results: The expected improvement (mean ± SD) of the QoL in Arm A at 3-months is 15.1 ± 17.7, while in Arm B is 6.1 ± 17.1 (Cohen d effect size=0.51, medium effect). Using a t test for independent samples, with 0.05 alpha and 0.80 1-beta will require 60 subjects per group. Considering an expected drop-out of 30%, a total of 172 patients will be recruited. Conclusions: The targeted exercise oncology through multidisciplinary team would like to provide a coordinated program of cancer care to improve health care quality, improve prognosis, increase survival times and QoL and reduce the risk of BC recurrence. Legal entity responsible for the study: Elena Barbieri. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.