Observational Cohort Study of Health-related Quality of Life in Patients Initiating Treatment With Chemotherapy for Metastatic Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Patients with moderate improvement in EORTC QLQ-C30 scoring
研究概览
简要总结
This is an observational, post-authorization, prospective follow-up, multi-centre, national study designed to describe the spectrum of health-related quality of life in patients with metastatic pancreatic cancer previously untreated with chemotherapy This study is designed to observe patients treated in routine clinical practice, without the exclusion limitations of a clinical trial. Patients will be enrolled in 7 Spanish sites. In all cases, the decision to treat patients will be performed prior to the decision to include the patient in the study.
Given the observational nature of the study, follow-up of patients will be performed according to standard clinical practice of each site.
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
- •Patients aged ≥ 18 years.
- •Patients diagnosed with metastatic pancreatic cancer confirmed histologically or cytologically
- •Patients with Karnofsky index ≥ 70 previously untreated with chemotherapy.
- •Patients with life expectancy ≥ 6 months.
- •Patients who will be treated with chemotherapy as first-line treatment for metastatic pancreatic cancer.*
- •Informed consent in writing or orally before witnesses.
- •The decision to prescribe any treatment will be clearly dissociated from the patient's inclusion in the study. Therefore, the choice of therapeutic strategy will be made according to usual clinical practice and independently by the doctor before assessing the possible involvement of the patients in the study and their corresponding inclusion in it
排除标准
- •Pregnant or breastfeeding.
- •Patients who are participating in an interventional clinical trial.
- •Patients who refuse to participate in this study.
- •Patients who have no ability to understand and respond to questions related to their health.
结局指标
主要结局
Patients with moderate improvement in EORTC QLQ-C30 scoring
时间窗: Up to 18 months
Number of participants with moderate improvement. Mild improvement in QoL (increased from ≥ 5 to \<10 points), moderate (increase of between ≥ 10 and \<20 points), and high (increase ≥ 20 points) in EORTC QLQ-C30) scoring.
Patients with high improvement in EORTC QLQ-C3 scoring
时间窗: Up to 18 months
Number of participants with high improvement. Mild improvement in QoL (increased from ≥ 5 to \<10 points), moderate (increase of between ≥ 10 and \<20 points), and high (increase ≥ 20 points) in EORTC QLQ-C30) scoring.
Impairment of mild EORTC QLQ-C30 score
时间窗: Up to 18 months
Time from enrolment to the first observation of a definite impairment of mild EORTC QLQ-C30 score (decrease from ≥ 5 to \<10 points without further improvement ≥ 5 points)
Mild/moderate/severe decline in EORTC QLQ-C30
时间窗: Up to 18 months
Number of patients with mild/moderate/severe decline in EORTC QLQ-C30 on the 30th day, 2nd month, 3rd month, 4th month, 5th month and 6th month.
Patients with mild improvement in Quality of life questionnaire - Current standard version 3.0 (EORTC QLQ-C30) scoring
时间窗: Up to 18 months
Number of participants with mild improvement. Mild improvement in QoL : (increased from ≥ 5 to \<10 points), moderate (increase of between ≥ 10 and \<20 points), and high (increase ≥ 20 points) in EORTC QLQ-C30) scoring.
Patients with mild impairment of EORTC QLQ-C30 scoring
时间窗: Up to 18 months
Number of participants with mild impairment. Mild impairment of QoL (decrease from ≥ 5 to \<10 points), moderate (decrease from ≥ 10 and \<20 points), and severe (decrease ≥ 20 points) in EORTC QLQ-C30 scoring); mean time to improvement of Quality of Life (QoL) of mild, moderate and high in EORTC QLQ-C30 scoring
Patients with moderate impairment of EORTC QLQ-C30 scoring
时间窗: Up to 18 months
Number of participants with moderate impairment.Mild impairment of QoL (decrease from ≥ 5 to \<10 points), moderate (decrease from ≥ 10 and \<20 points), and severe (decrease ≥ 20 points) in EORTC QLQ-C30 scoring); mean time to improvement of QoLof mild, moderate and high in EORTC QLQ-C30 scoring
Patients with high impairment of EORTC QLQ-C30 scoring
时间窗: Up to 18 months
Number of participants with high impairment. Mild impairment of QoL (decrease from ≥ 5 to \<10 points), moderate (decrease from ≥ 10 and \<20 points), and severe (decrease ≥ 20 points) in EORTC QLQ-C30 scoring); mean time to improvement of QoLof mild, moderate and high in EORTC QLQ-C30 scoring
Deterioration of severe EORTC QLQ-C30
时间窗: Up to 18 months
Time from enrolment to the first observation of a definite deterioration of moderate EORTC QLQ-C30 score (decrease from ≥ 10 and \<20 points without further improvement ≥ 10 points)
Deterioration of severe QLQ-C30
时间窗: Up to 18 months
Time from enrolment to the first observation of a definite deterioration of moderate EORTC QLQ-C30 score (decrease from ≥ 10 and \<20 points without further improvement ≥ 10 points)
Change from baseline of the EuroQoL Five Dimensions Questionnaire (EQ-5D).
时间窗: Up to 6 months
Change from baseline of the EQ-5D questionnaire at 15 days, 4 weeks, 2 months, 3rd month, 4th month, 5th month and 6th month
Deterioration of Moderate EORTC QLQ-C30 Score
时间窗: Up to 18 months
The time from enrollment to the first observation of a definite deterioration of moderate EORTC QLQ-C30 score (decrease from ≥ 10 and \<20 points without further improvement ≥ 10 points)
Definite deterioration of moderate EORTC QLQ-C30 Score
时间窗: Up to 18 months
Percentage of Time from enrollment to the first observation of a definite deterioration of moderate EORTC QLQ-C30 score (decrease from ≥ 10 and \<20 points without further improvement ≥ 10 points)
Patients with mild/moderate/high improvement in EORTC QLQ-C30
时间窗: Up to 18 months
Percentage of patients with mild/moderate/high improvement in EORTC QLQ-C30 on the 30th day, 2nd month, 3rd month, 4th month, 5th month and 6th month.
Change from baseline of the Karnofsky index
时间窗: Up to 6 months
Change from baseline of Karnofsky index at 15 days, 4 weeks, 2 months, 3rd month, 4th month, 5th month and 6th month.
次要结局
- Average variation of Karnofsky index versus EORTC QLQ-C30 score(Up to 6 months)
- Percentage of improved Karnofsky index(Up to 6 months)
- Average variation of Karnofsky index versus EQ-5D score(Up to 6 months)
- Mean of improvement of Karnofsky index(Up to 6 months)
- Mean of deterioration of Karnofsky index(Up to 6 months)
- Weight variation(Up to 6 months)
- Number of patients who use analgesics during treatment observation period (maximum 6 months).(Up to 6 months)
- Number of patients who use Painkillers during treatment observation period (maximum 6 months)(Up to 6 months)
- Duration of treatment(Up to 18 months)
- Rate response based on the treatment given.(Up to 18 months)
- Response to treatment determined by (Response Evaluation Criteria in Solid Tumors )RECIST v.1.1.(Up to 18 months)
- Overall survival determined by RECIST v.1.1.(Up to 30 months)
- Radiological examinations(Up to 18 months)
- Physical examinations(Up to 18 months)
- Feasibility of using the EORTC QLQ-C30 and EQ-5D questionnaires(Up to 6 months)
- Percentage of worse Karnofsky index(Up to 6 months)
- Delayed/Reduced dose treatment(Up to 18 months)
- Progression-free survival determined by RECIST v.1.1(Up to 30 months)
- Average dose of treatment (minimum, maximum)(Up to 18 months)
- Hematologic toxicity(Up to 30 months)
- Laboratory assessments(Up to 18 months)