Prospective Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 15
- 主要终点
- Impact on the HRQoL
研究概览
简要总结
Epidemiological, prospective and multicenter study to evaluate the utility of the BOMET-QoL questionnaire in patients with breast cancer (BC) and bone metastases (BM).
详细描述
Population: Patients over 18 with breast cancer and bone metastasis.
Inclusion criteria:
- Patient over 18 years of age.
- Patient diagnosed with breast cancer (BC) and bone metastases (BM).
- Patient who has granted informed consent in writing to participate in the study.
- Patient capable of understanding and completing the questionnaires.
Exclusion criteria:
- Patient with another type of disease that, in the investigator's opinion, could mask the study results.
- Patients with a life expectancy of less than 8 months.
- Patient who is participating in a clinical trial with an unregistered drug at the start of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Patient over 18 years of age.
- •Patient diagnosed with BC and BM.
- •Patient who has granted informed consent in writing to participate in the study.
- •Patient capable of understanding and completing the questionnaires
排除标准
- •Patient with another type of disease that, in the investigator's opinion, could mask the study results.
- •Patients with a life expectancy of less than 8 months.
- •Patient who is participating in a clinical trial with an unregistered drug at the start of the study.
结局指标
主要结局
Impact on the HRQoL
时间窗: Up to 24 months
Impact on the HRQoL of patients with BC and BM will be measured by the BOMET-QoL questionnaire in the context of normal clinical practice. The questionnaire will be administered to patients in each study visit from baseline visit to the final visit at 24 months. The score of the questionnaire will be measured as: Score: 0 - Always, 1 - Nearly always, 2 - Sometimes, 3 - Rarely, 4 - Never, were never is the best option and always means patient has a bad health condition.
次要结局
- Measurement properties of the BOMET-QoL questionnaire: feasibility(Up to 24 months)
- Measurement properties of the BOMET-QoL questionnaire: validity(Up to 24 months)
- Relation between Eastern Cooperative Oncology Group (ECOG) and HRQoL (BOMET-QoL scores).(Up to 24 months)
- Impact of skeletal-related events (SREs) on HRQoL (BOMET-QoL scores)(Up to 24 months)
- Correlation between visual analogue scale (VAS) score of pain and HRQoL (BOMET-QoL scores).(Up to 24 months)
- Measurement properties of the BOMET-QoL questionnaire: sensitivity to change(Up to 24 months)