Prehabilitation and Rehabilitation in Breast Cancer Surgery Patients - a Pilot Study
- Conditions
- SurgeryBreast CancerPrehabilitationLifestyleRehabilitation
- Interventions
- Behavioral: Prehabilitation and rehabilitation
- Registration Number
- NCT06076616
- Lead Sponsor
- Franciscus Gasthuis
- Brief Summary
Prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation/rehabilitation Prehabilitation and rehabilitation Patients in this arm follow a lifestyle counseling programme starting from diagnosis up to 6 months postoperatively.
- Primary Outcome Measures
Name Time Method Recruitment/consent rate From baseline to 6 months postoperatively 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.
Patient satisfaction From baseline to 6 months postoperatively 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.
Attendance rate From baseline to 6 months postoperatively 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
Withdrawals From baseline to 6 months postoperatively 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.
Selection bias From baseline to 6 months postoperatively To explore any evidence of selection bias in participants recruited into the study (assessed through participant characteristics at baseline).
Patient adherence From baseline to 6 months postoperatively 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.
- Secondary Outcome Measures
Name Time Method Likely changes in Health Related Quality of Life (HRQOL) Baseline, the day before surgery, 6 months postoperatively To investigate likely changes in the primary outcome measure HRQOL measured with the EORTC-QLQ-30 questionnaire at six months after surgery.
Likely changes in the number of postoperative complications 30 days after surgery Complications within 30 days after surgery, measured with the Comprehensive Complication Index (CCI)
Likely changes in mean score of the different BREAST-Q scales The questionnaire will be administered at enrolment and at six months after surgery. Measured using the BREAST-Q questionnaire
Likely changes in functional capacity (physical fitness) Baseline, the day before surgery, 6 months postoperatively Measured using the 6 minute walking test (6MWT)
Likely changes in postoperative functional recovery The day after surgery Measured the day after surgery with the MILAS and DEMMI questionnaires
Likely changes in mean score of the different EORTC-QLQ-30 scales which will be administered at enrolment and six months after surgery. The questionnaire will be administered at enrolment and at six months after surgery. Measured using the EORTC-QLQ-30 questionnaire
Likely changes in BMI Baseline, the day before surgery, 6 months postoperatively Body Mass Index
Likely changes in smoking status Measured at baseline and 6 months postoperatively Smoking status (yes/no) as assessed by the primary investigator
Likely changes in mean score of quality of life by means of the EORTC-BR23 questionnaire The questionnaire will be administered at enrolment and at six months after surgery. Measured using the EORTC-BR23 questionnaire
Likely changes in mean score of the EQ5D-5L questionnaire The questionnaire will be administered at enrolment and at six months after surgery. Measured using the EQ-5D-5L questionnaire
Trial Locations
- Locations (1)
Franciscus Gasthuis en Vlietland
🇳🇱Rotterdam, Zuid-Holland, Netherlands