protocolSection identificationModule nctId: NCT06266312, orgStudyIdInfo id: Maastricht UMC+, briefTitle: Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer, acronym: APRIORI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, collaborators name: Nationaal Fonds tegen Kanker, descriptionModule 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., conditionsModule conditions: Breast Cancer, conditions: Breast Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo masking: NONE, enrollmentInfo count: 11, type: ESTIMATED, armsInterventionsModule interventions name: A multimodal prehabilitation programme, outcomesModule primaryOutcomes measure: Recruitment rate (%), primaryOutcomes measure: Characteristics of included participants, primaryOutcomes measure: Attendance rate for MIET sessions (%), primaryOutcomes measure: Adherence rate, exercise relative dose intensity (ExRDI) MIET (%), primaryOutcomes measure: Reasons for not having executed a training session as intended, primaryOutcomes measure: Attendance rate HIIT + strength sessions (%), primaryOutcomes measure: Adherence rate, ExRDI HIIT training (%), primaryOutcomes measure: Adherence rate, ErXDI strength training (%), primaryOutcomes measure: Attendance rate for dietary consultations (%), primaryOutcomes measure: Percentage of use of the digital food diary 'Mijn Eetmeter'(%), primaryOutcomes measure: Percentage of days on which nutritional requirements were achieved (%), primaryOutcomes measure: Reasons for not achieving the nutritional requirements as intended, primaryOutcomes measure: Drop-out rate (%), primaryOutcomes measure: Time point of drop-out, primaryOutcomes measure: Reasons for drop-out, primaryOutcomes measure: Serious adverse events (SAE), primaryOutcomes measure: Study related adverse events, primaryOutcomes measure: Acceptance - Experiences with the multimodal lifestyle intervention, primaryOutcomes measure: Acceptance - Suitability of the multimodal lifestyle intervention and study procedures, primaryOutcomes measure: Acceptance - Barriers and enablers regarding participation in the study, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Nutritional status, secondaryOutcomes measure: Weight (kg), secondaryOutcomes measure: Height (cm), secondaryOutcomes measure: Body Mass Index (BMI), secondaryOutcomes measure: Energy and protein intake (absolute kcal and gr and gr/kg body weight per day), secondaryOutcomes measure: Energy requirements (kcal), secondaryOutcomes measure: Protein requirements, secondaryOutcomes measure: Circumference of upper arm and waist (cm), otherOutcomes measure: Chemotherapy Relative Dose Intensity (RDI), otherOutcomes measure: Treatment-related Side effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False