Observational Study of Quality of Live in Patients With Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Neoplasms
- Interventions
- Other: N/A (non-interventional study)
- Registration Number
- NCT02342847
- Lead Sponsor
- Celgene
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
-
Patients aged ≥ 18 years.
-
Patients diagnosed with metastatic pancreatic cancer confirmed histologically or cytologically
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Patients with Karnofsky index ≥ 70 previously untreated with chemotherapy.
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Patients with life expectancy ≥ 6 months.
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Patients who will be treated with chemotherapy as first-line treatment for metastatic pancreatic cancer.*
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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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pateints with metastatic pancreatic cancer N/A (non-interventional study) Patients diagnosed with metastatic pancreatic cancer confirmed histologically or cytologically, who will be treated with chemotherapy as first-line treatment of metastatic pancreatic cancer. This study is designed to observe patients treated in routine clinical practice, without the exclusion limitations of a clinical trial. The decision to treat patients will be performed prior to the decision to include the patient in the study. The follow-up of patients will be performed according to standard clinical practice of each site
- Primary Outcome Measures
Name Time Method Impairment of mild EORTC QLQ-C30 score 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)
Patients with moderate improvement in EORTC QLQ-C30 scoring 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 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.
Mild/moderate/severe decline in EORTC QLQ-C30 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 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 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 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 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 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 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). 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Average variation of Karnofsky index versus EQ-5D score Up to 6 months Average variation of Karnofsky index regarding patients with impairment or improvement of EQ-5D score.(0.1, 0.2, 0.3, 0.4 and 0.5 variation)
Average variation of Karnofsky index versus EORTC QLQ-C30 score Up to 6 months Average variation of Karnofsky index regarding patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score.
Percentage of improved Karnofsky index Up to 6 months Percentage of patients with improved Karnofsky basal index per month of treatment
Mean of improvement of Karnofsky index Up to 6 months Mean time to improvement of Karnofsky index from baseline
Mean of deterioration of Karnofsky index Up to 6 months Mean time to deterioration of Karnofsky index in patients who have previously improved after treatment.
Weight variation Up to 6 months Change in weight during treatment observation period (maximum 6 months). This outcome wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score
Number of patients who use analgesics during treatment observation period (maximum 6 months). Up to 6 months Number of patients who use analgesics during treatment observation period (maximum 6 months) with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score.
Number of patients who use Painkillers during treatment observation period (maximum 6 months) Up to 6 months Number of patients who use Painkillers during treatment observation period (maximum 6 months) with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score.
Duration of treatment Up to 18 months Average duration of treatment with chemotherapy for metastatic pancreatic cancer.
Rate response based on the treatment given. Up to 18 months Rate response (RR) wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score
Response to treatment determined by (Response Evaluation Criteria in Solid Tumors )RECIST v.1.1. Up to 18 months Response to treatment (RT) of the disease determined by RECIST v.1.1. . based on the treatment given This outcome wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score
Overall survival determined by RECIST v.1.1. Up to 30 months Overall survival (OS) of the disease determined by RECIST v.1.1. This outcome wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score
Radiological examinations Up to 18 months Number of radiological examinations per patient during treatment.
Physical examinations Up to 18 months Number of physical examinations per patient during treatment.
Feasibility of using the EORTC QLQ-C30 and EQ-5D questionnaires Up to 6 months Number of missing EORTC QLQ-C30 and EQ-5D questionnaires at 15 days, 4 weeks, 2 months, 3rd month, 4th month, 5th month and 6th month.
Percentage of worse Karnofsky index Up to 6 months Percentage of patients with worse Karnofsky basal index per month of treatment
Delayed/Reduced dose treatment Up to 18 months Number of patients with delayed dose or with reduced dose . This outcome wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score
Progression-free survival determined by RECIST v.1.1 Up to 30 months Progression-free survival (PFS) of the disease determined by RECIST v.1.1. based on the treatment given. This outcome wil be measured overall and per group of patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score
Average dose of treatment (minimum, maximum) Up to 18 months Average dose (minimum, maximum) of the treatment with chemotherapy for metastatic pancreatic cancer.
Hematologic toxicity Up to 30 months Number of participants with Grade 3-4 hematologic toxicity
Laboratory assessments Up to 18 months Number of laboratory assessments per patient during treatment
Trial Locations
- Locations (12)
Hospital Universitario Burgos
🇪🇸Burgos, Castilla Y León, Spain
Complejo Asistencial León
🇪🇸León, Castilla Y León, Spain
Germans Trias i Pujol
🇪🇸Badalona, Cataluña, Spain
Hospital Duran I Reynals (ICO Bellvitge)
🇪🇸Hospitalet de Llobregat, Cataluña, Spain
Hospital San Joan Reus
🇪🇸Reus, Cataluña, Spain
Hospital de Sabadell ( Parc Taulí)
🇪🇸Sabadell, Cataluña, Spain
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Vall d´Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital del Bierzo
🇪🇸León, Castilla Y León, Spain
Hospital Universitario Josep Trueta de Girona
🇪🇸Girona, Cataluña, Spain
Hospital Universitario Salamanca
🇪🇸Salamanca, Castilla Y León, Spain
Hospital del Mar
🇪🇸Barcelona, Cataluña, Spain