Prehabilitation and Rehabilitation in Breast Cancer Surgery Patients - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Recruitment/consent rate
研究概览
简要总结
Prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman with a confirmed breast cancer diagnosis
- •Planned surgical treatment of breast cancer
- •Age 18 years or older
- •Provision of written informed consent
排除标准
- •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.
结局指标
主要结局
Recruitment/consent rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Likely changes in Health Related Quality of Life (HRQOL)(Baseline, the day before surgery, 6 months postoperatively)
- Likely changes in functional capacity (physical fitness)(Baseline, the day before surgery, 6 months postoperatively)
- Likely changes in postoperative functional recovery(The day 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.(The questionnaire will be administered at enrolment and at six months after surgery.)
- Likely changes in the number of postoperative complications(30 days after surgery)
- Likely changes in mean score of the different BREAST-Q scales(The questionnaire will be administered at enrolment and at six months after surgery.)
- Likely changes in BMI(Baseline, the day before surgery, 6 months postoperatively)
- Likely changes in smoking status(Measured at baseline and 6 months postoperatively)
- 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.)
- Likely changes in mean score of the EQ5D-5L questionnaire(The questionnaire will be administered at enrolment and at six months after surgery.)