PhysSurg-B : Physical Activity in Relation to Surgical Operations, a Prospective Open-label Randomized Controlled Multicenter Study of the Effect of Physical Activity on Recovery After Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in self-reported physical and psychological recovery
研究概览
简要总结
The purpose of this study is to investigate whether a training program with intensified physical exercise prior to and after surgery for breast cancer enhances postoperative recovery.
详细描述
This study is designed as a randomised, controlled, non-blinded multicenter trial with two parallell study groups, intervention and control. The primary endpoint of recovery is measured within 12 months after surgery.
After randomisation, participants in the intervention group will be scheduled for an individual consultation with the physiotherapist, where the are advised to increase their Daily physical activiy level with an additional 30 minutes. The added physical activity is registered in an exercise diary daily.
All included participants will be asked to complete questionnaires at inclusion (I), 4 weeks (+/- 1 w) postoperatively (II) and 12 months (+/-1 month) postoperatively (III).
Data regarding patient characteristics, surgical details, postoperative events, complications according to Clavien - Dindo and additional treatment will be collected using eCRF: (I) 30 Days postoperatively, (II) 90 days postoperatively and (III) 12 months postoperatively. Data will also be retrieved from the Swedish National Breast Cancer Register, the Swedish Social Insurance Agency and the Swedish National Death Register.
Patrticipants who wish to be excluded from the study will be asked if already collected data may be analysed in the study.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All female patients at the participating hospital scheduled for breast cancer surgery will be asked to participate.
排除标准
- •Inability to understand given information.
- •Inability to perform the intervention, as assessed by the person performing inclusion.
- •Withdrawal of informed consent.
- •Male sex.
- •Stage IV breast cancer at diagnosis.
- •Neoadjuvant breast cancer treatment.
结局指标
主要结局
Change in self-reported physical and psychological recovery
时间窗: Inclusion, 4 weeks (+/- 1 week) and 12 months (+/- 1 month) postoperatively
Measured using validated questions within a questionnaire
Sick leave
时间窗: 12 months postoperatively
Data from the Swedish Social Insurance Agency (Försäkringskassan) on total number of days and the reasons (diagnosis) for any sick-leave episodes
次要结局
- Length of hospital stay(30 days postoperatively)
- Re-operations and re-admittances(12 months postoperatively)
- Health economy(12 months postoperatively)
- Mortality(3 and 5 years postoperatively)
- Adverse events(90 days postoperatively)
研究者
Roger Olofsson Bagge
MD, PhD
Sahlgrenska University Hospital, Sweden