Breast Cancer, Lifestyle, Prehabilitation, Rehabilitation, Surgery
Conditions
Brief summary
Prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer.
Interventions
BEHAVIORALPrehabilitation and rehabilitation
A personalized lifestyle counseling programme.
Sponsors
Franciscus Gasthuis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A pilot study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
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 | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 |
| 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 functional capacity (physical fitness) | Baseline, the day before surgery, 6 months postoperatively | Measured using the 6 minute walking test (6MWT) |
| 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 smoking status | Measured at baseline and 6 months postoperatively | Smoking status (yes/no) as assessed by the primary investigator |
| Likely changes in postoperative functional recovery | The day after surgery | Measured the day after surgery with the MILAS and DEMMI questionnaires |
Countries
Netherlands
Outcome results
None listed