Effects of a combined exercise and dietary intervention on body composition, physical functioning and fatigue in patients with ovarian cancer: results of the PADOVA trial.

BACKGROUND: Guidelines recommend to include exercise and dietary advice in standard care for patients with cancer, based on evidence primarily derived from patients with breast cancer. Its applicability to patients with ovarian cancer is uncertain due to differences in patient characteristics and treatments. The PADOVA trial examined the effectiveness of a combined exercise and dietary intervention on fat-free mass (FFM), physical functioning, and fatigue. METHODS: In total, 81 patients with ovarian cancer were randomised to the exercise and dietary intervention (n = 40) or control (n = 41) group. Measurements were performed before chemotherapy, after chemotherapy, and 12 weeks later. FFM was assessed by bioelectrical impedance analysis, and physical functioning and fatigue were assessed using questionnaires. Intervention effects were assessed on an intention-to-treat basis using linear mixed models. RESULTS: FFM and physical functioning increased, and fatigue decreased significantly over time in both groups. No significant difference between the groups were found for FFM (ß = -0.5 kg; 95% CI = -3.2; 2.1), physical functioning (ß = 1.4; 95% CI = -5.4; 8.3) and fatigue (ß = 0.7; 95% CI = -1.5; 2.8). CONCLUSIONS: During treatment, both groups improved in FFM, physical functioning, and fatigue. The intervention group, however, did not demonstrate additional benefits compared to the control group. This highlights the need for caution when extrapolating findings from different cancer populations to patients with ovarian cancer.

Demographic, clinical, and sociocognitive determinants related to physical activity and dietary intake in patients with ovarian cancer: A cross-sectional study.

OBJECTIVE: To study physical activity and dietary intake among patients with ovarian cancer and to examine which demographic, clinical, and sociocognitive determinants are associated with these behaviours. METHODS: This cross-sectional study included 139 patients with ovarian cancer scheduled for (neo)adjuvant chemotherapy. Physical activity was measured with the Physical Activity Scale for the Elderly questionnaire (PASE). Dietary intake was measured with a questionnaire assessing energy and protein intake and a questionnaire assessing adherence to the World Cancer Research Fund (WCRF) lifestyle recommendations. Demographic, clinical, and sociocognitive (e.g., self-efficacy) determinants of physical activity and dietary intake were examined using backward linear regression analyses. RESULTS: Patients reported a median PASE score of 50 (IQR 24-94), a mean ± SD dietary intake of 1831 ± 604 kcal/day and 76 ± 27 g protein/day. Patients adhered to 3 out of 5 WCRF lifestyle recommendations. The absence of comorbidities, lower physical outcome expectations, and higher cancer specific outcome expectations were independently associated with higher physical activity levels. Higher age, lower cancer specific outcome expectations, and higher diet-related self-efficacy were significantly associated with adhering to more WCRF lifestyle recommendations, whilst no variables associated with total caloric or protein intake were identified. CONCLUSIONS: Patients with ovarian cancer have low physical activity levels and a suboptimal diet, particularly low fruit and vegetable consumption and dietary fibre intake. Interventions aiming to improve physical activity and dietary intake could focus on increasing self-efficacy and outcome expectations, and should consider age and comorbidity as factors that may impact behaviour. TRIAL REGISTRATION: Netherlands Trial Registry NTR6300.

Tailoring of exercise and dietary interventions to adverse effects and existing comorbidities in patients with ovarian cancer receiving chemotherapy: a clinical vignettes study among expert physical therapists and dietitians.

PURPOSE: This study aims to capture the complex clinical reasoning process during tailoring of exercise and dietary interventions to adverse effects and comorbidities of patients with ovarian cancer receiving chemotherapy. METHODS: Clinical vignettes were presented to expert physical therapists (n = 4) and dietitians (n = 3). Using the think aloud method, these experts were asked to verbalize their clinical reasoning on how they would tailor the intervention to adverse effects of ovarian cancer and its treatment and comorbidities. Clinical reasoning steps were categorized in questions raised to obtain additional information; anticipated answers; and actions to be taken. Questions and actions were labeled according to the evidence-based practice model. RESULTS: Questions to obtain additional information were frequently related to the patients' capacities, safety or the etiology of health issues. Various hypothetical answers were proposed which led to different actions. Suggested actions by the experts included extensive monitoring of symptoms and parameters, specific adaptations to the exercise protocol and dietary-related patient education. CONCLUSIONS: Our study obtained insight into the complex process of clinical reasoning, in which a variety of patient-related variables are used to tailor interventions. This insight can be useful for description and fidelity assessment of interventions and training of healthcare professionals.

The delivery of exercise and dietary programs is not a one-size fits all approach but involves a complex clinical reasoning process.Therefore, protocols should not only describe the intervention content, but also the strategy on how to tailor the intervention to individual adverse effects and pre-existing comorbidities.Education of healthcare professionals delivering the intervention is important as these professionals need to have good clinical reasoning skills to adequately tailor the intervention.

Association between Energy Balance-Related Factors and Clinical Outcomes in Patients with Ovarian Cancer: A Systematic Review and Meta-Analysis.

Background: This systematic review and meta-analysis synthesized evidence in patients with ovarian cancer at diagnosis and/or during first-line treatment on; (i) the association of body weight, body composition, diet, exercise, sedentary behavior, or physical fitness with clinical outcomes; and (ii) the effect of exercise and/or dietary interventions. Methods: Risk of bias assessments and best-evidence syntheses were completed. Meta-analyses were performed when ≥3 papers presented point estimates and variability measures of associations or effects. Results: Body mass index (BMI) at diagnosis was not significantly associated with survival. Although the following trends were not supported by the best-evidence syntheses, the meta-analyses revealed that a higher BMI was associated with a higher risk of post-surgical complications (n = 5, HR: 1.63, 95% CI: 1.06−2.51, p = 0.030), a higher muscle mass was associated with a better progression-free survival (n = 3, HR: 1.41, 95% CI: 1.04−1.91, p = 0.030) and a higher muscle density was associated with a better overall survival (n = 3, HR: 2.12, 95% CI: 1.62−2.79, p < 0.001). Muscle measures were not significantly associated with surgical or chemotherapy-related outcomes. Conclusions: The prognostic value of baseline BMI for clinical outcomes is limited, but muscle mass and density may have more prognostic potential. High-quality studies with comprehensive reporting of results are required to improve our understanding of the prognostic value of body composition measures for clinical outcomes. Systematic review registration number: PROSPERO identifier CRD42020163058.

Rationale and study protocol of the Physical Activity and Dietary intervention in women with OVArian cancer (PADOVA) study: a randomised controlled trial to evaluate effectiveness of a tailored exercise and dietary intervention on body composition, physical function and fatigue in women with ovarian cancer undergoing chemotherapy.

INTRODUCTION: As a consequence of ovarian cancer and its treatment, many women with ovarian cancer have to deal with reduced physical function, fatigue, and loss of weight and/or muscle mass, compromising quality of life. Exercise and dietary interventions can positively influence body composition, physical fitness and function, and fatigue in patients with cancer. However, there are no data from randomised controlled trials on the effectiveness of exercise and dietary interventions in patients with ovarian cancer. Due to a complex disease trajectory, a relatively poor survival and distinct disease-induced and treatment-induced side effects, it is unclear whether exercise and dietary interventions that were shown to be feasible and effective in other types of cancer produce comparable results in patients with ovarian cancer. The aim of this article is to present the design of the multicentre randomised controlled Physical Activity and Dietary intervention in OVArian cancer trial and to describe how the exercise and dietary intervention is tailored to specific comorbidities and disease-induced and treatment-induced adverse effects in patients with ovarian cancer. METHODS AND ANALYSIS: Adult women with primary epithelial ovarian cancer who are scheduled to undergo first-line (neo)adjuvant chemotherapy (n=122) are randomly allocated to a combined exercise and dietary intervention or a usual care control group during chemotherapy. Primary outcomes are body composition, physical function and fatigue. Outcome measures will be assessed before the start of chemotherapy, 3 weeks after completion of chemotherapy and 12 weeks later. The exercise and dietary intervention was tailored to ovarian cancer-specific comorbidities and adverse effects of ovarian cancer and its treatment following the i3-S strategy. ETHICS AND DISSEMINATION: This study has been approved by the medical ethical committee of the Amsterdam UMC (reference: 018). Results of the study will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: Netherlands Trial Registry (NTR6300).

Validity of the "Rate-a-Plate" Method to Estimate Energy and Protein Intake in Acutely Ill, Hospitalized Patients.

BACKGROUND: Prevalence of malnutrition in hospitals has been reported around 20% and increases during hospitalization. The "Rate-a-Plate" method has been developed to monitor dietary intake and identify patients whose nutrition status deteriorates during hospitalization, but has not yet been validated. The objective was to study the validity and reliability of the method (phase 1) and redesign and revalidate a revised version (phase 2). METHODS: Detailed food records provided a reference method. A priori difference of >20% in energy or protein between the reference and the "Rate-a-Plate" method was determined as clinically relevant. Intraclass correlation coefficients were used to determine the reliability. RESULTS: In phase 1, 24 patients were included with a total 67 test days. In phase 2, 14 patients were included, 28 test days. In phase 1, the "Rate-a-Plate" method underestimated intake by 422 kcal (29%, ICC 0.349, 95% CI 304-541) and 5.7 g protein (10%, ICC 0.511, 95% CI 0.0-11.5). Underestimation was found in 65% and 23% for energy and protein intake, respectively. Underestimation was higher when patients had higher intake. In phase 2, underestimation was 109 kcal (7%, ICC 0.788, 95% CI -273 to 56) and 3.7 g protein (6%, ICC 0.905, 95% CI -8.4 to 1.0). In 32% and 21% of the cases, energy and protein intake were underestimated. CONCLUSION: The revised version of the "Rate-a-Plate" method is a valid method to monitor energy and protein intake of hospitalized patients and can be filled out by nutrition assistants. A larger validation study is required.