QoL and Treatment Compliance for Pre-menopausal Patients With HR+ Breast Cancer Using GnRHa as Ovarian Function Suppression(OFS) Treatment in the Chinese Population: a Real-world Observational Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 562
- 试验地点
- 1
- 主要终点
- Treatment compliance
研究概览
简要总结
The purpose of this study is to assess the patient's feedback from using GnRHa depot formulation in postoperative, premenopausal patients with hormone receptor-positive breast cancer.
详细描述
This was a real world, observational study of adjuvant therapy with GnRHa for OFS in postoperative, premenopausal women with endocrine responsive breast cancer. This trial is designed to compare patients' QOL and treatment compliance measured by FACT-B and self-administered questionnaires during OFS treatment period. Total score of FACT-B and self-administered questionaries, and change from baseline will be calculated and summarized descriptively. Change from baseline will be compared between GnRHa 3-month and GnRHa 1-month using ANCOVA model with baseline value as a covariate.The number depends on the patients who received questionnaire during 18 months recruitment in planned 10 sites. This analytical plan assumes homogeneity across 10 sites so that strata is not considered.
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
- •Age≥18 years old; Both or either ER+ or PgR+ primary tumor; T1-T3, any N, and M0 according to the TNM classification; Any type of breast surgery (includes breast conserving surgery and breast cancer radical surgery); Any type of preoperative and/or postoperative adjuvant chemotherapy prior to enrollment; History of regular menstruation and not having chemical menopause (FSH≥40 mIU/mL and E2<10 pg/mL) within 12 weeks after completion of the postoperative chemotherapy; Previously using GnRH-a 1M or 3M as OFS treatment for at least one time; Capable of receiving other study drug like Tamoxifen or AI; Eastern Cooperative Oncology Group performance status of Grade 0 or 1.
排除标准
- •Uncapable of receiving endocrine therapy for any clinical or other reason; Bilateral oophorectomy or ovarian irradiation Inflammatory breast cancer or bilateral breast cancer; Multiple cancers or a history of cancer in other organs; Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent prolonged follow-up.
研究组 & 干预措施
GnRHa 1-month
Patients using GnRHa 1-month depot
干预措施: 1M GnRHa (Drug)
GnRHa 3-month
Patients using GnRHa 3-month depot
干预措施: 3M GnRHa (Drug)
结局指标
主要结局
Treatment compliance
时间窗: Change will be assessed over two time points (baseline and 3 months)
Treatment compliance will be measured by self-administered questionnaire. Scale score range: 0-40. The score includes forward items (the higher score means the better adherence) and the reverse items (the higher score means the worse adherence).
Quality of life (QOL)
时间窗: Change will be assessed over two time points (baseline and 3 months)
QOL of participant will be measured by Functional Assessment of Cancer Therapy -Breast (FACT-B) questionnaires, a 37-item instrument designed to measure five domains of QOL in breast cancer patients. Score range: 0-148. The score includes forward items (the higher score means the better of quality of life) and the reverse items (the higher score means the worse quality of life).
次要结局
未报告次要终点
研究者
Zhimin Shao
Professor Shao
Fudan University