NCT02774213已完成不适用
An Observational Study to Collect Data Characterizing Analgesia in Patients Suffering From Bone Metastasis Induced Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 8
- 主要终点
- Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)
研究概览
简要总结
Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic treatments and be treated for pain relief exactly as they would normally be by the Investigator based on their needs. During their regular visits to the Investigator, patients will complete questionnaires and Clinical Pain Assessments.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bone tumors or bone metastasis from any primary cancer origin that is supported by histological or radiological investigations.
- •Patients having been or being treated for their bone metastasis and/or their primary cancer.
- •Patients who require analgesic treatment for unsatisfactory pain relief.
- •Patients will be required to score at least 4 on the WAPS 11-point NRS during the week preceding enrollment.
- •Patients undergoing or not a radiotherapy program provided visit procedures are performed before any radiotherapy sessions if scheduled on the same visit days.
- •Are men or women of at least 18 years of age.
- •Are reliable and willing to make themselves available for the entire duration of the study and are willing to follow study procedures.
- •Have given written informed consent approved by the relevant Ethics Committee governing the study site.
排除标准
- •Patients having had a major surgery within 28 days prior to signing Informed Consent Document or planning to have a major surgery during the study.
- •Patients having a life expectancy < 3 months according to Investigator judgment.
- •Patients having poor nutritional status or whose condition is unstable or who could be rapidly deteriorating in such a way that they would not be able to complete the study.
- •Patients with a current or recent history unrelated to their cancer condition, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study.
- •Patients having a Karnofsky performance status below 70% or WHO score (Eastern Cooperative Oncology Group (ECOG)/Zubrod score) above
- •Are Investigator site staffs directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •Any other relevant medical disorder likely to interfere with the trial or represent a risk for the patient.
- •Patients under legal protection, according to the country law.
- •Patients currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to the national law.
结局指标
主要结局
Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)
时间窗: Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)
11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was the Weekly Average Pain Score (WAPS), over the week first visit (the last 7 days); end of study measure was the mean of the APS of the last 7 days prior to last visit (Visit 2)
次要结局
- Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Worst Pain Score (WPS)(Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2))
- Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)(Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2))
- Patient's Change From Baseline of Investigator Global Assessment of Changes (IGAC)(Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2))
- Patient's Change From Baseline of Patient Global Assessment of Changes (PGAC)(Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2))
- Patient's Change From Baseline of Pain Intensity Measured After Clinical Pain Assessments (CPAs)(Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2))
- Patient's Change From Baseline of Quality-of-Life Questionnaire in 30 Questions (QLQ-C30).(Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2))
- Patient's Change From Baseline of Pain Interference as Measured by the Brief Pain Inventory (BPI)(Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2))
研究者
研究点 (8)
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