Breast Reconstruction and Radiotherapy: a Nationwide Cohort Study on Care Evaluation and Optimization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Patient satisfaction at 1 year
研究概览
简要总结
If the whole breast is removed because of breast cancer, several options for breast reconstruction are available. All these options have an increased complication risk if a patient has been or will be treated with radiotherapy. However, only a few high-quality studies addressed patient satisfaction and complication risks, both in terms of timing (prior to or after irradiation) and type of reconstruction (implant or own tissue). As radiotherapy indications expand and more patients desire a reconstruction, this is a progressively relevant issue. Through this nationwide prospective study, the investigators aim to identify the most ideal treatment strategy by comparing different reconstruction options in terms of patient reported outcomes (PROs), toxicity, oncological safety and costs. These results will enable improvement of shared decision-making and cost-effectiveness of breast reconstruction strategies in case of 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
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Diagnosed with unilateral non-metastatic breast cancer
- •(to be) Treated with mastectomy and to be treated with adjuvant radiotherapy
- •Willing and able to provide written informed consent
排除标准
- •History of DCIS or invasive breast cancer
- •Previous thoracic radiotherapy treatment
- •History of other malignancies (except for patients with basal or squamous cell skin cancer, in situ carcinoma of the cervix and patients who are disease-free at least 5 years following successful treatment for other malignancies)
结局指标
主要结局
Patient satisfaction at 1 year
时间窗: From enrollment to one year follow-up after treatment.
The primary objective is to assess patient reported outcomes at 1 year (after mastectomy), by means of the validated questionnaire BREAST-Q. With the BREAST-Q questionnaire, four domains will be evaluated (psychosocial well-being (score ranges from 10 to 50), physical well-being (score ranges from 10 to 30), sexual well-being (score ranges from 6 to 30) and satisfaction with breasts (score ranges from 4 to 16) and higher scores indicate better outcomes.
Patient quality of life at 1 year
时间窗: From enrollment to one year follow-up after treatment.
The primary objective is to assess patient reported outcomes at 1 year (after mastectomy), by means of the validated questionnaire EQ-5D-5L. The EQ-5D-5L questionnaire consists of two parts: the descriptive system, with a minimum value of 5 and maximum value of 25 (higher scores mean worse quality of life) and the visual analogue scale, with a minimum value of 0 and maximum value of 100 (higher scores mean better quality of life).
次要结局
- Patient satisfaction at 3 and 5 years(From enrollment to 3 and 5 years follow-up after treatment.)
- Patient quality of life at 3 and 5 years(From enrollment to 3 and 5 years follow-up after treatment.)
- Complications prior to and following radiotherapy(From enrollment to end of study follow-up (i.e. 5 years after treatment).)
- Cost-effectiveness and consumption of medical care and materials.(Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).)
- Time to adjuvant treatment (radiotherapy/systemic therapy).(Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).)
- Breast cancer recurrence rates at 3, and 5 years(Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).)
- Recurrence free interval, disease free survival and overall survival at 3 and 5 years.(Patients will be followed until 5 years after mastectomy (or 5 years after delayed breast reconstruction if applicable).)
研究者
Janine M. Simons MD PhD
Principal Investigator
Erasmus Medical Center