Abstract 238P
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.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Elena Barbieri.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.