Prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A personalized lifestyle counseling programme.
Franciscus Gasthuis en Vlietland
Rotterdam, South Holland, Netherlands
Recruitment/consent rate
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. We define a success criterion of 40% of the total number of participants invited to be recruited to the pilot study.
Time frame: From baseline to 6 months postoperatively
Attendance rate
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
Time frame: From baseline to 6 months postoperatively
Patient adherence
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.
Time frame: From baseline to 6 months postoperatively
Withdrawals
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.
Time frame: From baseline to 6 months postoperatively
Patient satisfaction
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.
Time frame: From baseline to 6 months postoperatively
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Selection bias
To explore any evidence of selection bias in participants recruited into the study (assessed through participant characteristics at baseline).
Time frame: From baseline to 6 months postoperatively
Likely changes in Health Related Quality of Life (HRQOL)
To investigate likely changes in the primary outcome measure HRQOL measured with the EORTC-QLQ-30 questionnaire at six months after surgery.
Time frame: Baseline, the day before surgery, 6 months postoperatively
Likely changes in BMI
Body Mass Index
Time frame: Baseline, the day before surgery, 6 months postoperatively
Likely changes in functional capacity (physical fitness)
Measured using the 6 minute walking test (6MWT)
Time frame: Baseline, the day before surgery, 6 months postoperatively
Likely changes in the number of postoperative complications
Complications within 30 days after surgery, measured with the Comprehensive Complication Index (CCI)
Time frame: 30 days after surgery
Likely changes in smoking status
Smoking status (yes/no) as assessed by the primary investigator
Time frame: Measured at baseline and 6 months postoperatively
Likely changes in postoperative functional recovery
Measured the day after surgery with the MILAS and DEMMI questionnaires
Time frame: The day after surgery
Likely changes in mean score of the different BREAST-Q scales
Measured using the BREAST-Q questionnaire
Time frame: The questionnaire will be administered at enrolment and at six months after surgery.
Likely changes in mean score of quality of life by means of the EORTC-BR23 questionnaire
Measured using the EORTC-BR23 questionnaire
Time frame: The questionnaire will be administered at enrolment and at six months after surgery.
Likely changes in mean score of the different EORTC-QLQ-30 scales which will be administered at enrolment and six months after surgery.
Measured using the EORTC-QLQ-30 questionnaire
Time frame: The questionnaire will be administered at enrolment and at six months after surgery.
Likely changes in mean score of the EQ5D-5L questionnaire
Measured using the EQ-5D-5L questionnaire
Time frame: The questionnaire will be administered at enrolment and at six months after surgery.