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

NCT02342847 | Completed

• 1 other identifier: CEL-CPM-2014-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 12

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.

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (22)

• Feasibility of using the EORTC QLQ-C30 and EQ-5D questionnaires

  Up to 6 months

• Average variation of Karnofsky index versus EORTC QLQ-C30 score

  Up to 6 months

• Percentage of improved Karnofsky index

  Up to 18 months

• Average variation of Karnofsky index versus EQ-5D score

  Up to 6 months

• Percentage of improved Karnofsky index

  Up to 6 months

Study Arms (1)

Pateints with metastatic pancreatic cancer

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)

Interventions

N/A (non-interventional study) OTHER

Pateints with metastatic pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who will be treated with any of the first line chemotherapy treatments at the participating site approved for the treatment of Metastasic Pancreatic Cancer (MPC) will be included consecutively according to the criteria set. 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. The patients selected for the study must meet all inclusion criteria and none of the exclusion.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (12)

Hospital Universitario Burgos

Burgos, Castille and León, 09006, Spain

Location

Complejo Asistencial León

León, Castille and León, 24071, Spain

Location

Hospital del Bierzo

León, Castille and León, 24404, Spain

Location

Hospital Universitario Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Germans Trias i Pujol

Badalona, Catalonia, 08916, Spain

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital Vall d´Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Universitario Josep Trueta de Girona

Girona, Catalonia, 17007, Spain

Location

Hospital Duran I Reynals (ICO Bellvitge)

L'Hospitalet de Llobregat, Catalonia, 08908, Spain

Location

Hospital San Joan Reus

Reus, Catalonia, 43204, Spain

Location

Hospital de Sabadell ( Parc Taulí)

Sabadell, Catalonia, 08208, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, 008026, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Lorena Pellín, MD

  Celgene Spain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 21, 2015
• Study Start: December 10, 2014
• Primary Completion: November 9, 2016
• Study Completion: November 16, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

ES (12)