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

Pancreatic Neoplasms Clinical Trial

— aLIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342847
• Other study ID #: CEL-CPM-2014-01
• Status: Completed
• Start date: December 10, 2014
• Est. completion date: November 16, 2018

Study information

• Verified date: January 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 16, 2018
• Est. primary completion date: November 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Other:
• N/A (non-interventional study)

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol	Badalona	Cataluña
Spain	Hospital del Mar	Barcelona	Cataluña
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall d´Hebron	Barcelona	Cataluña
Spain	Hospital Universitario Burgos	Burgos	Castilla Y León
Spain	Hospital Universitario Josep Trueta de Girona	Girona	Cataluña
Spain	Hospital Duran I Reynals (ICO Bellvitge)	Hospitalet de Llobregat	Cataluña
Spain	Complejo Asistencial León	León	Castilla Y León
Spain	Hospital del Bierzo	León	Castilla Y León
Spain	Hospital San Joan Reus	Reus	Cataluña
Spain	Hospital de Sabadell ( Parc Taulí)	Sabadell	Cataluña
Spain	Hospital Universitario Salamanca	Salamanca	Castilla Y León

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Percentage of improved Karnofsky index	Percentage of patients with improved Karnofsky basal index per month of treatment	Up to 18 months
Secondary	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
Secondary	Percentage of improved Karnofsky index	Percentage of patients with improved Karnofsky basal index per month of treatment	Up to 6 months
Secondary	Percentage of worse Karnofsky index	Percentage of patients with worse Karnofsky basal index per month of treatment	Up to 6 months
Secondary	Mean of improvement of Karnofsky index	Mean time to improvement of Karnofsky index from baseline	Up to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Duration of treatment	Average duration of treatment with chemotherapy for metastatic pancreatic cancer.	Up to 18 months
Secondary	Average dose of treatment (minimum, maximum)	Average dose (minimum, maximum) of the treatment with chemotherapy for metastatic pancreatic cancer.	Up to 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hematologic toxicity	Number of participants with Grade 3-4 hematologic toxicity	Up to 30 months
Secondary	Radiological examinations	Number of radiological examinations per patient during treatment.	Up to 18 months
Secondary	Laboratory assessments	Number of laboratory assessments per patient during treatment	Up to 18 months
Secondary	Physical examinations	Number of physical examinations per patient during treatment.	Up to 18 months