breast cancer breast malignancy
Conditions
Interventions
The intervention consists of prehabilitation and rehabilitation through an
individualised lifestyle coaching programme, starting from diagnosis up to 6
months postoperatively.
Lifestyle coaching wil
Sponsors
Franciscus
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Woman with a confirmed breast cancer diagnosis 2. Planned surgical treatment of breast cancer 3. Age 18 years or older 4. Provision of written informed consent
Exclusion criteria
Exclusion criteria: 1. Severe mental retardation, which limits the ability to follow instructions independently 2. Severe psychiatric problems, which limits the ability to follow instructions independently 3. Legal incapacity 4. Language barrier: If we cannot find a lifestyle coach who speaks the patient's language, unfortunately we cannot offer the lifestyle coaching in its entirety, and this option will be omitted for the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pilot study parameters - To estimate patient recruitment/consent rate to the prehabilitation/rehabilitation group Enrolment logs will be recorded for all patients who meet the eligibility criteria. Reasons for non-participation will be recorded and data entered into an excel spreadsheet. We define a success criterion of 40% of the total number of participants invited to be recruited to the research evaluation. - To estimate patient attendance,measured by the number of sessions attended out of 10, reasons for non-attendance will be collected and withdrawals tracked. We will consider an attendance rate of 80% satisfactory. - To estimate patient adherence monitored with the aid of the wearables. Adherence is defined as at least 150 min of moderate intensity exercise and at least two strength training sessions per week. Exercise instructions are based on the Health Council's exercise guidelines. We will consider an adherence of 70% as satisfactory. - To estimate the number of withdrawals, defined as the proportion of patients who quit the intervention before reaching the primary endpoint (HRQOL at six months after surgery). Information about the reasons for withdrawal will be collected and entered into an excel spreadsheet. - To estimate patient satisfaction with the programme assessed during three interviews: at four weeks, at three months after surgery and at the end of the study. Satisfaction is defined as: satisfaction with the lifestyle coach, satisfaction with the duration of the intervention, satisfaction with the physical training programme. Patients will be given room for their own input to improve the intervention. - To investigate likely changes in the primary outcome measure HRQOL measured with the EORTC-QLQ-30 questionnaire at six months after surgery. - To investigate likely changes in the secondary outcome measures: - BMI (kg/cm2) measured at baseline, the day before surgery and at six months after surgery. - Functional capac | — |
Countries
Netherlands
Contacts
Public ContactSM Wooldrik
Franciscus
Outcome results
None listed