Chinese Multicenter Prospective Registry of Breast Cancer Patient Reported Outcome and Oncological Safety -Oncoplastic and Conventional BCS Cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,000
- 主要终点
- EORTC QLQ-C30
研究概览
简要总结
Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic BCS could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as conventional BCS does. However, these studies that focused on patient-reported outcomes and oncological safety were mainly from one institution or of small sample size. The variations across hospitals and regions were not fully analyzed. A multicenter prospective patient report outcome (PROs) and oncological safety will be planned to assess the PROs and safety for Chinese breast cancer patients who will undergo oncoplastic and conventional breast-conserving surgery (OBCS). This study follows the Helsinki Declaration and Chinese rules. All patients will be asked to sign the informed consent and will be followed up 24 months after operations. All data will be collected.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed;
- •Non-metastatic Breast cancer patients confirmed by pathology;
- •Adult (>18 years old, <80 years old);
- •Must undergo oncoplastic or conventional breast-conserving surgery;
排除标准
- •Inflammatory breast cancer, Stage IV breast cancer patients;
- •Have other malignant tumors;
- •Pregnancy women;
- •Have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients;
- •Refuse breast-conserving surgery.
结局指标
主要结局
EORTC QLQ-C30
时间窗: Change from baseline at 1 year and 2 years post-operatively
The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
Health-related quality of life：EORTC QLQ-BR23
时间窗: Change from baseline at 1 year and 2 years post-operatively
EORTC QLQ-BR-23 consists of 23 questions related to breast cancer. The questionnaire will be self-administered and will be given in patient's mother tongue. EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
Patients' satisfaction：BREAST-Q score
时间窗: Change from baseline at 6 months, 1 year and 2 years post-operatively
The Breast-Q© is a patient reported outcome measure (PROM) for breast surgery that was rigorously developed to accurately measure patient reported satisfaction and quality of life (QOL). (http://www.mskcc.org/mskcc/shared/Breast-Q/index.html). The BREAST-Q was developed and validated with adherence to international guidelines. This PROM is composed of six scales that address: 1) psychosocial well-being, 2) physical well-being, 3) sexual well-being, 4) satisfaction with breasts, 5) satisfaction with outcome, and 6) satisfaction with care. Each module generates a Q-score on a 0-100 scale that can be used for quantitative analysis to enable statistical comparison of the pre- to the post-operative state.
Recurrence-free survival
时间窗: up to 24 months
Recurrence-free survival (RFS) was calculated as time from breast cancer diagnosis until locoregional (LRRFS) or distant recurrence (DRFS) or death due to breast cancer, whichever came first
次要结局
- Complication's ratio(up to 24 months)
- Cosmetic results(Change from baseline at 1 year and 2 years post-operatively)
- Overall survival(up to 24 months)
研究者
Zhiyong Yu
PhD
Shandong Cancer Hospital and Institute