Prehabilitation and Rehabilitation in Breast Cancer Surgery Patients - a Pilot Study

Study Overview
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Brief Summary
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Prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer.

Official Title
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Prehabilitation and Rehabilitation in Breast Cancer Surgery Patients - a Pilot Study

Conditions
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Breast Cancer, Lifestyle, Rehabilitation, Prehabilitation, Surgery

Intervention / Treatment
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* Behavioral: Prehabilitation and rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Woman with a confirmed breast cancer diagnosis Planned surgical treatment of breast cancer Age 18 years or older Provision of written informed consent Exclusion criteria Severe mental retardation, which limits the ability to follow instructions independently Severe psychiatric problems, which limits the ability to follow instructions independently Legal incapacity 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation/rehabilitation<br>Patients in this arm follow a lifestyle counseling programme starting from diagnosis up to 6 months postoperatively. | Behavioral: Prehabilitation and rehabilitation<br>* A personalized lifestyle counseling programme.<br>|
| No Intervention: Usual care<br>Patients in this arm follow usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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. | 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. | From baseline to 6 months postoperatively | 
| Selection bias | To explore any evidence of selection bias in participants recruited into the study (assessed through participant characteristics at baseline). | From baseline to 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, the day before surgery, 6 months postoperatively | 
| Likely changes in BMI | Body Mass Index | Baseline, the day before surgery, 6 months postoperatively | 
| Likely changes in functional capacity (physical fitness) | Measured using the 6 minute walking test (6MWT) | 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) | 30 days after surgery | 
| Likely changes in smoking status | Smoking status (yes/no) as assessed by the primary investigator | Measured at baseline and 6 months postoperatively | 
| Likely changes in postoperative functional recovery | Measured the day after surgery with the MILAS and DEMMI questionnaires | The day after surgery | 
| Likely changes in mean score of the different BREAST-Q scales | Measured using the BREAST-Q questionnaire | 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 | 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 | 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 | The questionnaire will be administered at enrolment and at six months after surgery. |