Observational Study of Quality of Live in Patients With Metastatic Pancreatic Cancer

Study Overview
=================
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.

Official Title
-----------------
Observational Cohort Study of Health-related Quality of Life in Patients Initiating Treatment With Chemotherapy for Metastatic Pancreatic Cancer

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Other: N/A (non-interventional study)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pateints with metastatic pancreatic cancer<br>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 | Other: N/A (non-interventional study)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with mild improvement in Quality of life questionnaire - Current standard version 3.0 (EORTC QLQ-C30) scoring | 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. | Up to 18 months | 
| Patients with mild impairment of EORTC QLQ-C30 scoring | 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 | Up to 18 months | 
| Patients with moderate improvement in EORTC QLQ-C30 scoring | 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. | Up to 18 months | 
| Patients with moderate impairment of EORTC QLQ-C30 scoring | 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 | Up to 18 months | 
| Patients with high improvement in EORTC QLQ-C3 scoring | 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. | Up to 18 months | 
| Patients with high impairment of EORTC QLQ-C30 scoring | 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 | Up to 18 months | 
| Impairment of mild EORTC QLQ-C30 score | 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) | Up to 18 months | 
| Deterioration of Moderate EORTC QLQ-C30 Score | 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) | Up to 18 months | 
| Deterioration of severe EORTC QLQ-C30 | 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) | Up to 18 months | 
| Definite deterioration of moderate EORTC QLQ-C30 Score | 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) | Up to 18 months | 
| Mild/moderate/severe decline in EORTC QLQ-C30 | 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. | Up to 18 months | 
| Patients with mild/moderate/high improvement in EORTC QLQ-C30 | 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. | Up to 18 months | 
| Deterioration of severe QLQ-C30 | 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) | Up to 18 months | 
| Change from baseline of the EuroQoL Five Dimensions Questionnaire (EQ-5D). | Change from baseline of the EQ-5D questionnaire at 15 days, 4 weeks, 2 months, 3rd month, 4th month, 5th month and 6th month | Up to 6 months | 
| Change from baseline of the Karnofsky index | Change from baseline of Karnofsky index at 15 days, 4 weeks, 2 months, 3rd month, 4th month, 5th month and 6th month. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of using the EORTC QLQ-C30 and EQ-5D questionnaires | 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. | Up to 6 months | 
| Average variation of Karnofsky index versus EORTC QLQ-C30 score | Average variation of Karnofsky index regarding patients with mild, moderate and high impairment and mild, moderate and severe improvement of EORTC QLQ-C30 score. | Up to 6 months | 
| Percentage of improved Karnofsky index | Percentage of patients with improved Karnofsky basal index per month of treatment | Up to 18 months | 
| Average variation of Karnofsky index versus EQ-5D score | 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) | Up to 6 months | 
| Percentage of improved Karnofsky index | Percentage of patients with improved Karnofsky basal index per month of treatment | Up to 6 months | 
| Percentage of worse Karnofsky index | Percentage of patients with worse Karnofsky basal index per month of treatment | Up to 6 months | 
| Mean of improvement of Karnofsky index | Mean time to improvement of Karnofsky index from baseline | Up to 6 months | 
| Mean of deterioration of Karnofsky index | Mean time to deterioration of Karnofsky index in patients who have previously improved after treatment. | Up to 6 months | 
| Weight variation | 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 | Up to 6 months | 
| Number of patients who use Painkillers during treatment observation period (maximum 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. | Up to 6 months | 
| Number of patients who use analgesics during treatment observation period (maximum 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. | Up to 6 months | 
| Duration of treatment | Average duration of treatment with chemotherapy for metastatic pancreatic cancer. | Up to 18 months | 
| Average dose of treatment (minimum, maximum) | Average dose (minimum, maximum) of the treatment with chemotherapy for metastatic pancreatic cancer. | Up to 18 months | 
| Delayed/Reduced dose treatment | 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 | Up to 18 months | 
| Rate response based on the treatment given. | 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 | Up to 18 months | 
| Response to treatment determined by (Response Evaluation Criteria in Solid Tumors )RECIST v.1.1. | 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 | Up to 18 months | 
| Overall survival determined by RECIST v.1.1. | 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 | Up to 30 months | 
| Progression-free survival determined by RECIST v.1.1 | 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 | Up to 30 months | 
| Hematologic toxicity | Number of participants with Grade 3-4 hematologic toxicity | Up to 30 months | 
| Radiological examinations | Number of radiological examinations per patient during treatment. | Up to 18 months | 
| Laboratory assessments | Number of laboratory assessments per patient during treatment | Up to 18 months | 
| Physical examinations | Number of physical examinations per patient during treatment. | Up to 18 months |