nctId: NCT06266312 id: Maastricht UMC+ briefTitle: Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer acronym: APRIORI overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-02-20 date: 2024-02-20 name: Maastricht University Medical Center class: OTHER name: Nationaal Fonds tegen Kanker briefSummary: The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy. conditions: Breast Cancer conditions: Breast Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A prospective, single-centre, longitudinal mixed-methods feasibility study will be performed to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer. primaryPurpose: PREVENTION masking: NONE count: 11 type: ESTIMATED name: A multimodal prehabilitation programme measure: Recruitment rate (%) measure: Characteristics of included participants measure: Attendance rate for MIET sessions (%) measure: Adherence rate, exercise relative dose intensity (ExRDI) MIET (%) measure: Reasons for not having executed a training session as intended measure: Attendance rate HIIT + strength sessions (%) measure: Adherence rate, ExRDI HIIT training (%) measure: Adherence rate, ErXDI strength training (%) measure: Attendance rate for dietary consultations (%) measure: Percentage of use of the digital food diary 'Mijn Eetmeter'(%) measure: Percentage of days on which nutritional requirements were achieved (%) measure: Reasons for not achieving the nutritional requirements as intended measure: Drop-out rate (%) measure: Time point of drop-out measure: Reasons for drop-out measure: Serious adverse events (SAE) measure: Study related adverse events measure: Acceptance - Experiences with the multimodal lifestyle intervention measure: Acceptance - Suitability of the multimodal lifestyle intervention and study procedures measure: Acceptance - Barriers and enablers regarding participation in the study measure: Fatigue measure: Cardiorespiratory fitness measure: Muscle strength measure: Nutritional status measure: Weight (kg) measure: Height (cm) measure: Body Mass Index (BMI) measure: Energy and protein intake (absolute kcal and gr and gr/kg body weight per day) measure: Energy requirements (kcal) measure: Protein requirements measure: Circumference of upper arm and waist (cm) measure: Chemotherapy Relative Dose Intensity (RDI) measure: Treatment-related Side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False