A Prospective Multi-modal Cohort Study of Local Treatment-related Toxicities and Quality of Life in Chinese Breast Cancer Patients (PERSEVERE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 3
- 主要终点
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
研究概览
简要总结
This study, called PERSEVERE, examines how local treatment for early breast cancer affects people's health and daily lives over time.
People who join the study will have early-stage breast cancer and receive treatment such as surgery and other therapies that are used before or after surgery. The study does not include people with late-stage (metastatic) breast cancer.
Researchers want to learn about short- and long-term side effects that can happen during or after treatment. These may include tiredness, trouble sleeping, emotional distress, pain, or changes in heart or lung function. The study also looks at how these effects impact participants' quality of life.
Participants will be asked to complete surveys about how they feel. They will also have health checks, such as heart tests, lung function tests, and blood samples. Tissue samples from surgery will also be collected.
The goal is to understand better how different people respond to breast cancer treatment and find ways to support long-term recovery.
详细描述
PERSEVERE is a prospective, multi-modal cohort study designed to evaluate treatment-related toxicities and quality of life in people with stage I-III early breast cancer receiving local therapy in China. Participants will be eligible if they either:
Receive neoadjuvant therapy (such as chemotherapy or targeted therapy) prior to surgery, or
Undergo surgery followed by postoperative adjuvant therapy, including chemotherapy, radiotherapy, endocrine therapy, or targeted therapy.
The study does not include individuals with recurrent or metastatic breast cancer.
Study Objectives and Methods This study aims to understand the short- and long-term physical, psychological, and social effects of breast cancer treatment and how they impact participants' recovery and daily life.
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
- 是
入选标准
- •Women aged 18 years or older
- •Diagnosed with stage I, II, or III invasive breast cancer confirmed by pathology or cytology
- •No signs of metastatic disease (cancer that has spread to other parts of the body)
- •Scheduled to receive local treatment, including:
- •And/or neoadjuvant or adjuvant therapy such as chemotherapy, radiation, hormone therapy, or targeted therapy
- •Willing and able to complete health questionnaires and attend follow-up visits
- •Has given written informed consent to join the study
排除标准
- •Have metastatic breast cancer or local recurrence
- •Have already received curative treatment (surgery, chemo, etc.) for the current breast cancer before joining the study
- •Are currently pregnant or breastfeeding
- •Have a history of another cancer within the past 5 years (except for non-melanoma skin cancer or in-situ cervical cancer)
- •Are unable to participate in the study due to mental, physical, or legal reasons (for example, under legal guardianship or imprisonment)
结局指标
主要结局
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
时间窗: Baseline, 1week, 1 month, 3 months, 6 months, 12 months, annually up to 5 years
Quality of life will be measured using the EORTC QLQ-C30, a 30-item questionnaire that includes a global health status/QoL scale, five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, nausea/vomiting, pain), and several single-item symptom measures. Score range: Each scale is transformed to a 0-100 scale. Interpretation: For functional and global health status scales, higher scores indicate better functioning or quality of life. For symptom scales, higher scores indicate worse symptom burden. Changes from baseline will be analyzed across follow-up timepoints.
次要结局
- Trajectories and Risk Factors for Cancer-Related Fatigue Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Fatigue Module (EORTC QLQ-FA12)(Baseline, 1 week, 1 month, 3 months, 6 months, 12 months, then annually up to 5 years)
研究者
FangYi
Chief Physician and Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences