The objective of this multicenter randomized controlled trial is to compare a 6-month exercise and nutrition intervention (intervention group, IG) aimed at maintaining or improving physical functioning and quality of life with usual care (control group, CG) in ovarian cancer patients. The main question it aims to answer is: • Can an exercise and nutrition program improve physical performance during and after active treatment for ovarian cancer? Participants of the IG will undergo: * Weeks 1-18: approximately 15-30 minutes of daily exercise (cardio, resistance, and balance exercises); nutritional counseling focusing on malnutrition (protein-energy malnutrition). * Weeks 19-25: More intense daily training; nutritional counseling focusing on the Mediterranean diet. The study design includes 3 survey time points: * Baseline: After surgery and before starting chemotherapy * T1: After chemotherapy (week 19) * T2: After intervention (week 26) The primary outcome is: • 6-minute walk test, 6 months after enrollment (T2)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
185
Patients will be instructed on how to use the Physitrack app. At the start of chemotherapy, patients will be contacted by physiotherapists and dietitians from the University Medical Center Hamburg-Eppendorf either via video call using the app or by phone to discuss the first week's program. Patients can either complete the exercise program at home using the app or receive printed exercise plans in the mail to be completed with the physical therapist of their choice. The exercise program is adjusted weekly until week 9. After week 10, adjustments are made every two weeks. For each program, patients receive a 30-minute counseling session to discuss the exercises. The 30-minute nutritional counseling session occurs every two weeks. For patients receiving neoadjuvant chemotherapy, the exercise program is interrupted for the time of surgery and the two-week recovery period and resumed when chemotherapy is resumed.
Charité Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGUniversitätskrebszentrum Dresden
Dresden, Germany
NOT_YET_RECRUITINGEvang. Klinik Essen-Mitte
Essen, Germany
RECRUITINGUniversitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGUniversitätsklinikum Schleswig-Holstein
Kiel, Germany
NOT_YET_RECRUITINGKlinikum rechts der Isar der Technischen Universität München Ismaniger Straße 22
München, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Tübingen
Tübingen, Germany
NOT_YET_RECRUITING6 Minute Walk Test (distance in metre)
Sub-maximal exercise test used to assess aerobic capacity and endurance
Time frame: Change in the total distance from T2 (6 months after enrollment) to baseline as target
6 Minute Walk Test (distance in metre)
Sub-maximal exercise test used to assess aerobic capacity and endurance
Time frame: Change in the total distance from T1 (end of chemotherapy, approx. week 18-19) to baseline as target
Global physical activity questionnaire (GPAQ)
Physical activity in minutes per day, MET minutes per week
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Assessment of body composition using bioelectrical impedance analysis (BIA)
Bioelectrical impedance analyzers use an alternating electric current to measure the two components of bioelectrical impedance in the human body, resistance r and reactance Xc. In electrophysiological terms, resistance (per unit volume) correlates negatively with the amount of body fluid (body water and fat-free mass (FFM)) through which the current flows, while reactance correlates positively with the mass of body cells. The magnitude of Xc in relation to R is expressed as the phase angle (PA). From the measured R and Xc values and other subject data, additional indicators of body composition (e.g., total body water, fat-free mass, and fat mass) can be estimated using specific prediction equations based on modeling assumptions that are generally population-, age-, sex-, fat-, and disease-specific.
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Grip force dynamometer
Hand gripping force (kg)
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Polyneuropathy; item derived from EORTC CIPN20 (Item 9)
Problems standing or walking, because can't longer feel the ground under feet
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Patient Health Questionnaire-9 (PHQ-9)
Depression screening
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Generalized Anxiety Disorder using GAD-2
Anxiety
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Adherence to a Mediterranean diet (MEDAS)
Adherence to a Mediterranean diet is assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS).
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
EORTC QLQ-C30
Quality of life (multidimensional) across 10 subscales
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
EORTC OV-28
Quality of life (multidimensional) focusing on ovarian cancer across 7 subscales
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
EORT FA-12
Quality of life (multidimensional) focusing on fatigue
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Nutritional Risk Screening (NRS 2002)
Malnutrition risk
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Brief Social Support Scale (BS6)
Social support (tangible support, emotional-informational support)
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
Patient Activation Measure (PAM-13)
Patient Activation Measure
Time frame: Baseline, T1: After chemotherapy (week 19), T2: (6 months after enrollment) to baseline which is after intervention (week 26))
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