Skip to main content

Table 2 Study population: inclusion and exclusion criteria

From: Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study)

Inclusion criteria (all criteria must apply):
• Women with a pathogenic BRCA1 or BRCA2 germline mutation
• Age between 18 and 69 years
• Written informed consent
 
Exclusion criteria:
• Metastatic tumor disease
• Expectancy of life <3 years
• Limited cardiovascular and lung diseases (instable CHC, heart failure stage IV, COPD 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 status scale <60%
• Women with VO2 max > 150% of general population
• Women with an exercise capacity <50 W
• Food allergies not allowing consumption of a Mediterranean dietary pattern
• Vegans
• BMI < 15 kg/m2
• Pregnancy
• Insufficient knowledge of the German language
• Current participation in other lifestyle intervention trials