跳至主要内容
临床试验/NCT05724758
NCT05724758尚未招募不适用

Patient Reported Outcomes After Oncoplastic Breast Conserving Surgery

Brust-Zentrum AG0 个研究点目标入组 100 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Change of patient satisfaction with their breasts pre- and post breast-conserving surgery

研究概览

简要总结

The goal of this study is to assess patient satisfaction after oncoplastic breast conserving surgery. With the help of a breast-questionnaire the patient satisfaction will be assessed before the surgery and 4 weeks, 6 months and 1 year after the operation. The main question it aims to answer are: Does breast conserving surgery improve quality of life.

type of study: cohort study, observational

OCBS = oncoplastic breast conserving surgery BCT = breast conserving therapy DCIS = ductal carcinoma in situ

participant population/health conditions

  • Patients with newly diagnosed breast cancer, that can be treated breast conserving
  • the participants have to be at least 18 years old

Participants will fill out a questionnaire pre surgery, 4 weeks, 6 months and 1 year after the surgery. The individual questionnaires will be compared.

详细描述

The management of breast cancer has undergone a significant shift over the last century. The advances in systemic therapy have not only improved the overall prognosis however also allowed for less radical surgery and more breast conservable efforts. The term oncoplastic breast conserving surgery was first coined in the early 90s where breast cancer surgery was performed while incorporating plastic surgical techniques. Therefore, this enabled the preservation of the natural breast shape with good aesthetic outcomes. Over the years oncoplastic breast conserving surgery has become widely accepted and adopted into routine clinical practice by most breast cancer surgeons. The oncological safety surrounding oncoplastic breast conserving surgery have been well established. Rates of positive surgical margins and re-excision rates have been shown to be similar to traditional lumpectomy operations. Complication rates are also comparable and oncoplastic breast conserving surgery does not result in delays in adjuvant treatments. However, many surgeons would concur that the most significant benefit of oncoplastic breast conserving surgery (OBCS) is patient satisfaction and the potential improvement in their quality of life.

Patient reported outcomes (PROMs) allow us to objectively assess patient satisfaction and the impact the intervention has had onto their lives. Incorporating PROMs into daily clinical practice would not only facilitate shared-decision making but also allow us to tailor clinical management to suit individual patient needs. This study however also aims to assess the patient reported outcome after breast surgery and in the follow up time (after radiotherapy, ...).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BCT oncoplastic surgery technique
  • Women > 18 years

排除标准

  • Previously treated ipsilateral breast cancer or DCIS
  • Severe psychological illness by doctors' discretion (as taking part in a study could increase anxiety) or severe dementia, that stops them to consent to the procedure
  • Pregnant women
  • Distant metastatic disease (M1)

结局指标

主要结局

Change of patient satisfaction with their breasts pre- and post breast-conserving surgery

时间窗: before the surgery and 4 weeks after the surgery

To assess patient satisfaction using BREAST-Q over the duration of the breast cancer clinical management and follow up i.e., pre-, and postoperative: 4 weeks, 6 months and 1 year after the surgery.

Change of quality of Life pre- and post breast-conserving surgery

时间窗: before the surgery and 4 weeks after the surgery

To assess Quality of Life using BREAST-Q over the duration of the breast cancer clinical management and follow up i.e., pre-, and postoperative: 4 weeks, 6 months and 1 year after the surgery.

次要结局

  • impact of age (>70 and < 60 years old) on Patient reported outcome measures(baseline and 4 weeks postoperative)

研究者

申办方类型
Other
责任方
Sponsor

相似试验