Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors.

BACKGROUND: Breast cancer (BC) is the most common invasive cancer in women, and exercise can significantly improve the outcomes of BC survivors. MoviS (Movement and Health Beyond Care) is a randomized controlled trial aimed to evaluate the potential health benefits of exercise and proper nutritional habits. This study aims to assess the efficacy of aerobic exercise training in improving quality of life (QoL) and health-related factors in high-risk BC. METHODS: One hundred seventy-two BC survivor women, aged 30-70 years, non-metastatic, stage 0-III, non-physically active, 6-12 months post-surgery, and post chemo- or radiotherapy, will be recruited in this study. Women will be randomly allocated to the intervention arm (lifestyle recommendations and MoviS Training) or control arm (lifestyle recommendations). The MoviS training consists of 12 weeks of aerobic exercise training (2 days/week of supervised and 1 day/week of unsupervised exercise) with a progressive increase in exercise intensity (40-70% of heart rate reserve) and duration (20-60 min). Both arms will receive counseling on healthy lifestyle habits (nutrition and exercise) based on the World Cancer Research Fund International (WCRF) 2018 guidelines. The primary outcome is the improvement of the QoL. The secondary outcomes are improvement of health-related parameters such as Mediterranean diet adherence, physical activity level, flexibility, muscular fitness, fatigue, cardiorespiratory fitness (estimated maximal oxygen uptake), echocardiographic parameters, heart rate variability (average of the standard deviations of all 5 min normal to normal intervals (ASDNN/5 min) and 24 h very low and low frequency), and metabolic, endocrine, and inflammatory serum biomarkers (glycemia, insulin resistance, progesterone, testosterone, and high-sensitivity C-reactive protein). DISCUSSION: This trial aims to evaluate if supervised exercise may improve QoL and health-related factors of BC survivors with a high risk of recurrence. Findings from this project could provide knowledge improvement in the field of exercise oncology through the participation of a multidisciplinary team that will provide a coordinated program of cancer care to improve healthcare quality, improve prognosis, increase survival times and QoL, and reduce the risk of BC recurrence. TRIAL REGISTRATION: ClinicalTrials.gov  NCT04818359 . Retrospectively registered on March 26, 2021.

Validation of Self-Reported Anthropometric Measures and Body Mass Index in a Subcohort of the DianaWeb Population Study.

INTRODUCTION: DianaWeb is a community-based participatory project open to Italian breast cancer patients. The aim of the study was to assess the effectiveness of a lifestyle intervention in improving the prognosis after patients received diagnosis and surgery/chemotherapy. The DianaWeb study uses an interactive Web site (www.dianaweb.org) to monitor patients' lifestyles, and to obtain clinical and anthropometric data. Although detailed instructions for measuring height, body weight, waist circumference, and blood pressure (BP) are provided, individuals might tend to overestimate or underestimate those parameters. The aims of the present study were: (1) to compare self-recorded data with those from standardized ambulatory measurements; (2) to determine the trueness of a subject classification in the overweight/obesity or hypertensive subgroup on the basis of the patients' own measurements and estimates; and (3) to identify confounding variables. PATIENTS AND METHODS: We compared self-reported with ambulatory measurements in a subgroup of 200 randomly selected women of approximately 1000 enrolled in the DianaWeb study (from September 2016 to March 2018). RESULTS: Bland-Altman analysis showed a close agreement for self-reported and ambulatory-measured height, weight, and body mass index (BMI). On the contrary, women overestimated waist circumference and underestimated BP. Cohen κ statistics showed fair agreement only for hypertension. Binary logistic regression analysis showed that BMI and diastolic BP self-measurements were biased according to age. CONCLUSION: The results suggest that self-reported height, weight, and BMI are satisfactorily accurate for patients in the DianaWeb study, such as accuracies of overweight/obese and central obesity classification, and that these data can be useful for our research.