A Multicentre, Cohort Study to Assess the Impact on SYMptom Burden and Patient Health-related Quality of Life of Afatinib Treatment in Advanced Non-small Cell Lung Cancer in a Real World Setting in Greece.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months of Treatment
研究概览
简要总结
This non-interventional study will include a representative sample of patients with locally advanced or metastatic NSCLC harboring Epidermal Growth Factor Receptor (EGFR)-mutations in Greece. Eligible NSCLC patients, for whom the physician has decided to initiate treatment with the study medication (afatinib, GIOTRIF®) will be treated according to the local prescribing information and standard medical practice in terms of visit frequency and types of assessments performed.
The study will investigate the impact of GIOTRIF (Afatinib) on patients' disease-related symptom burden and Health-Related Quality of Life (HRQoL) in a real world clinical setting in Greece.The Average Symptom Burden Index (ASBI) score of the Lung Cancer Symptom Scale (LCSS) in eligible patients, after 6 months of therapy, will be analyzed.
The overall study duration period is expected to be 60 months, including a 48-month enrollment period and a minimum 12-month follow-up period.
详细描述
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients with non-small cell lung cancer (NSCLC) treated with afatinib
Patients with advanced/metastatic non-small cell lung cancer (NSCLC) in Greece treated with afatinib. Patients were treated as per the routine medical practice in terms of visit frequency, types of assessments performed and with adherence to the local prescribing requirements for afatinib. Patients were observed in the context of the study until the end of study participation, defined as a maximum of 48 months after afatinib treatment initiation or until disease progression, death, withdrawal of consent, unacceptable toxicity, study completion or physician's decision whichever occurred earlier.
干预措施: afatinib (Drug)
结局指标
主要结局
Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months of Treatment
时间窗: Baseline and 6 months following start of treatment.
Number of patients who experience a minimum clinically important improvement in symptoms is reported. A patient was categorized as having an improvement if the mean score of any two consecutive post-baseline Average Symptom Burden Index (ASBI) score of Lung Cancer Symptom Scale (LCSS) assessments for that patient was at least 10 points below the patient's ASBI score of LCSS at enrolment, over 6 months of treatment. The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Each item is scored on a 100-millimeter (mm) Visual Analogue Scale (VAS), with score reported from 0 to 100, with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions was not completed, the ASBI score was not calculated.
次要结局
- Patient-rated Total Lung Cancer Symptom Scale (LCSS) Score(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Anxiety/Depression(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Fatigue(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Dyspnoea(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Patient-rated Average Symptom Burden Index (ASBI) Score of Lung Cancer Symptom Scale (LCSS)(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Loss of Appetite(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Cough(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Pain(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Overall Symptomatic Distress(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Interference With Normal Activity(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Global Quality of Life (QoL)(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Mobility(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Haemoptysis(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Self-care(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Percentage of Patients With Reported Problems for theEuropean Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Usual Activities(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Pain/Discomfort(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- EQ-VAS Score(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 0(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 1(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 2(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 3(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 4(Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.)
- Ratio of Afatinib Tablets Actually Taken to Doses Prescribed Over the Study Participation Period(Up to 42 months.)
- Number of Patients With a Reason for Missing Afatinib Tablets(Up to 42 months.)
- Number of Patients With a Reason for Discontinuation of Afatinib(Up to 42 months.)
- Number of Patients With a Reason for Treatment Interruptions(Up to 42 months.)
- Number of Participants With Afatinib Interruptions or Dose Modifications(Up to 42 months.)
- Number of Patients With a Reason for Dose Reduction(Up to 42 months.)
- Number of Patients With a Reason for Dose Increase(Up to 42 months.)