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Completed

NCT Number: NCT02342847

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Burgos, Burgos, Castille and León, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N/A (non-interventional study)

Other

Primary outcomes

  1. Patients with mild improvement in Quality of life questionnaire - Current standard version 3.0 (EORTC QLQ-C30) scoring

    Time frame: 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.

  2. Patients with mild impairment of EORTC QLQ-C30 scoring

    Time frame: 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

  3. Patients with moderate improvement in EORTC QLQ-C30 scoring

    Time frame: 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.

  4. Patients with moderate impairment of EORTC QLQ-C30 scoring

    Time frame: 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

  5. Patients with high improvement in EORTC QLQ-C3 scoring

    Time frame: 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.

  6. Patients with high impairment of EORTC QLQ-C30 scoring

    Time frame: 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

  7. Impairment of mild EORTC QLQ-C30 score

    Time frame: 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)

  8. Deterioration of Moderate EORTC QLQ-C30 Score

    Time frame: 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)

  9. Deterioration of severe EORTC QLQ-C30

    Time frame: 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)

  10. Definite deterioration of moderate EORTC QLQ-C30 Score

    Time frame: 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)

  11. Mild/moderate/severe decline in EORTC QLQ-C30

    Time frame: 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.

  12. Patients with mild/moderate/high improvement in EORTC QLQ-C30

    Time frame: 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.

  13. Deterioration of severe QLQ-C30

    Time frame: 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)

  14. Change from baseline of the EuroQoL Five Dimensions Questionnaire (EQ-5D).

    Time frame: 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

  15. Change from baseline of the Karnofsky index

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Average variation of Karnofsky index versus EORTC QLQ-C30 score

    Time frame: 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.

  3. Percentage of improved Karnofsky index

    Time frame: Up to 18 months

    Percentage of patients with improved Karnofsky basal index per month of treatment

  4. Average variation of Karnofsky index versus EQ-5D score

    Time frame: 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)

  5. Percentage of improved Karnofsky index

    Time frame: Up to 6 months

    Percentage of patients with improved Karnofsky basal index per month of treatment

  6. Percentage of worse Karnofsky index

    Time frame: Up to 6 months

    Percentage of patients with worse Karnofsky basal index per month of treatment

  7. Mean of improvement of Karnofsky index

    Time frame: Up to 6 months

    Mean time to improvement of Karnofsky index from baseline

  8. Mean of deterioration of Karnofsky index

    Time frame: Up to 6 months

    Mean time to deterioration of Karnofsky index in patients who have previously improved after treatment.

  9. Weight variation

    Time frame: 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

  10. Number of patients who use Painkillers during treatment observation period (maximum 6 months)

    Time frame: 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.

  11. Number of patients who use analgesics during treatment observation period (maximum 6 months).

    Time frame: 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.

  12. Duration of treatment

    Time frame: Up to 18 months

    Average duration of treatment with chemotherapy for metastatic pancreatic cancer.

  13. Average dose of treatment (minimum, maximum)

    Time frame: Up to 18 months

    Average dose (minimum, maximum) of the treatment with chemotherapy for metastatic pancreatic cancer.

  14. Delayed/Reduced dose treatment

    Time frame: 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

  15. Rate response based on the treatment given.

    Time frame: 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

  16. Response to treatment determined by (Response Evaluation Criteria in Solid Tumors )RECIST v.1.1.

    Time frame: 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

  17. Overall survival determined by RECIST v.1.1.

    Time frame: 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

  18. Progression-free survival determined by RECIST v.1.1

    Time frame: 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

  19. Hematologic toxicity

    Time frame: Up to 30 months

    Number of participants with Grade 3-4 hematologic toxicity

  20. Radiological examinations

    Time frame: Up to 18 months

    Number of radiological examinations per patient during treatment.

  21. Laboratory assessments

    Time frame: Up to 18 months

    Number of laboratory assessments per patient during treatment

  22. Physical examinations

    Time frame: Up to 18 months

    Number of physical examinations per patient during treatment.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Acronym: aLIVE

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jan 21, 2015
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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