OptiBra Study, Optimal Postoperative Bra After Breastcancer Surgery - an RCT
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Pain intensity measure
研究概览
简要总结
This study evaluates how two different types of postoperative bra 1) standard bra, soft VS 2) compression bra compression after breast cancer surgery affect pain, seroma, other symptoms and complications, and the womans experience of comfort
详细描述
Background
Breast cancer is the most common form of cancer in women and in Sweden about 9700 women are affected each year.Therefore, it is of great importance to promote the rehabilitation process by minimizing unnecessary symptoms and complications that may arise during a breast cancer treatment. Surgery is the primary cure for breast cancer and about 40% need to undergo a major surgical procedur and major operations also involve an increased risk of complications and symptoms.
Pain is the most common reported symptom in women who are operated on for breast cancer other complications after surgery that may occur are seroma, wound infektions and swelling.
No published evidence exists for the benefit and effect in pain relief from wearing a bra as a support after breast surgery is available, therefore it is important to evaluate useful and simple methods that the patient can manage herself that can minimize the experience of pain and other symptom after breast cancer surgery.
At Karolinska University Hospital's breast cancer center, women who undergo breast surgery are offered a bra after surgery in order to provide good support for the patient to feel safe, comfortable and minimize complications and symptoms such as pain. Two different types of bra are used and, according to the clinical staff at Karolinska's breast cancer center clinical experience, there is disagreement about which type of bra gives the optimal effect in different surgical procedures to reduce symptoms and post-operative complications. Neither is there enough knowledge about and how women experience comfort from the bra they received from the healthcare, which is important as the bra should be used large parts of the day for about 3 weeks after the procedure. Lack of knowledge makes it difficult to provide person-centered care for each individual. The purpose of this study is to compare two different types of bra after breast cancer surgery and to evaluate whether a particular type of bra affects the perception of pain, other symptoms, the occurrence of complications and experiences of bra comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Not blinded but randomized
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women from 18 years
- •Malignant tumor of the breast gland to undergo surgery.
排除标准
- •Men with breast cancer Women with benign tumors Women with health factors where the assessment is that BRA use is not necessary or possible.
研究组 & 干预措施
standard
Standard bra, soft
干预措施: OptiBra study (Other)
compression bra
experimental bra, compression and stabile
干预措施: OptiBra study (Other)
结局指标
主要结局
Pain intensity measure
时间窗: 21 days from operations day
VAS scale ( Visual analoge scale) , each item is score, 0= no pain to 10= pain as bad as can be. yielding at total between 0 and 10
次要结局
- Seroma(This will be examine 21 days after the surgery at the revisit to surgon)
- Postoperative breastsymptoms(report every day, 21 days after operation)
- Patients experience of symptoms and comfort(Reported basline and 21 days after operation)
- Pain medication intake after surgery(Report every day, 21 days after operation)
研究者
Malin Backman
Medicine Doctor, Oncologynurse
Karolinska University Hospital