Background
Design/methods
Trial design
Participants
Inclusion criteria (all criteria must apply): • Women with a BRCA1 or BRCA2 germline mutation • Age over 18 years • Written informed consent |
Exclusion criteria: • Ongoing chemo- or radiation therapy (recruitment is possible 6 weeks after completing therapy) • Metastatic tumor disease • Expectancy of life <3 years • Limited cardiovascular and lung diseases (unstable CHC, heart failure stage IV, chronic obstructive pulmonary disease GOLD IV, maximal blood pressure at rest >160/100 mmHg) • Significant orthopedic problems not allowing exercise • Serious diseases not allowing a participation in group interventions (e.g., psychiatric or internal ailment) • Karnofsky index <60 % • Women with an exercise capacity <50 watts • Food allergies not allowing consumption of a Mediterranean dietary pattern • Vegans • BMI <15 kg/m2 • Pregnancy • Insufficient knowledge of the German language • Lack of compliance • Current participation in other lifestyle intervention trials |
Intervention group
Physical activity
Nutrition
Psychological support
Control group
Measurements
Medical history
Sociodemographics
Medical radiation exposure
Study satisfaction questionnaire
Cardiovascular assessment
Exercise testing/spiroergometry
International Physical Activity Questionnaire
Examination of physical constitution
Blood tests
Routine blood parameters measured in recruiting centers: • Glutamate pyruvate transaminase (GPT), alanine aminotransferase (ALT) • Total cholesterol • High-density lipoprotein (HDL) cholesterol • Low-density lipoprotein (LDL) cholesterol • Triglycerides • Glucose • Blood cell count • Gamma-glutamyl transferase (GGT) |
Blood parameters measured in central or special laboratories: • Insulin • Proencephalin A 119 D159 (Sphingotec GmbH) • Proneurotensin 1–117 (Sphingotec GmbH) • High-sensitivity C-reactive protein (hsCRP) • Omega-3, 6, and 9 fatty acid content in the membrane of erythrocytes |
Stool tests
EPIC Food Frequency Questionnaire
Mediterranean Diet Adherence Screener
Measurement of quality of life
Measurement of optimism (Life Orientation Test-Revised)
Measurement of chronic stress (Trier Inventory for Chronic Stress) [34]
Measurement of attitudes and views on physical exercise and healthy eating
Study endpoints
Primary outcome measures: • Mediterranean Diet Adherence Screener (MEDAS) score • Body mass index (BMI) • Ventilatory threshold 1 (VT1) determined by bicycle spiroergometry For all three outcome measures, the change between baseline and 12 months will be analyzed. Secondary outcome measures: Psychology: • Stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire • Grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire • Quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical activity: • Maximum oxygen consumption (VO2 peak), as measured by spiroergometry • Oxygen consumption (VO2) and watts at ventilation threshold 1 (VT1 and VT2), as measured by spiroergometry • Physical activity, as measured by the International Physical Activity Questionnaire (IPAQ) Nutrition: • Mediterranean Diet Adherence Screener (MEDAS) score • Dietary habits and calorie intake, as measured by the European Prospective Investigation into Cancer and Nutrition Study Food Frequency Questionnaire (EPIC-FFQ) • BMI Breast cancer incidence and mortality • Breast cancer incidence • Overall and breast cancer mortality rate Other outcome measures: • Attitudes and beliefs regarding physical training and healthy diet, as measured by the “Bewertung koerperlicher Aktivitaet und Ernaehrung” (BKAE) questionnaire • Satisfaction with the study • Body fat content, as measured by skinfold measurement • Tobacco and alcohol consumption • Omega 3, 6, and 9 fatty acids in the erythrocyte membrane • Serum cholesterol including serum high- and low-density lipoprotein cholesterol • Serum triglycerides, glucose, high-sensitivity C-reactive protein, and insulin • Serum proenkephalin and proneurotensin • Hospitalization days for breast cancer If appropriate, secondary and other outcome measures will be analyzed as the change from baseline over time of all available time points. |