Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units (CAVIDIOPAL)

March 2, 2018 updated by: Angelini Farmacéutica

Patients treated in Palliative Care Units are potentially fragile patients, especially in our case, which are cancer patients. The management of these patients is usually done from experience, because these patients rarely meet criteria for clinical trials, as their inclusion could affect results obtained in the trial.

There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in palliative care units according to routine clinical practice. For this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain treated in palliative care units as well as the characteristics of these patients.

This post-authorization observational study will assess the quality of life of patients with breakthrough cancer pain treated in Palliative Care Units in Spanish hospitals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Lleida, Spain, 25198
        • Hospital Arnau de Vilanova
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Ourense, Spain, 32005
        • Complejo Hospitalario de Ourense
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Toledo, Spain, 45005
        • Hospital Virgen De La Salud
    • Barcelona
      • Mollet del Vallès, Barcelona, Spain, 08100
        • Hospital de Mollet
    • Illes Baleares
      • Palma, Illes Baleares, Spain, 07007
        • Hospital Sant Joan de Deu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with breakthrough cancer pain attended in Palliative Care Units will be included

Description

Inclusion Criteria:

  • Patients > 18 years
  • Patients with advanced cancer
  • Patients attended in Palliative Care Units
  • Life expectancy> 3 months
  • Written informed consent
  • Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm

Exclusion Criteria:

  • Serious psychiatric disorder, cognitive impairment or any disease or condition that prevents the collection of data
  • Patients with evidence of opioid addiction or history of drug or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breakthrough Cancer Pain
No intervention (Non-interventional study)
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life according EORTC QLQ-C30 questionnaire
Time Frame: Baseline and 4 weeks
Change in punctuation of the EORTC QLQ-C30 questionnaire between week 4 and baseline.
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with neuropathic, visceral, somatic and mixed pain
Time Frame: Baseline (the day that patient sign the informed consent form)
Percentage of patients with neuropathic, visceral, somatic and mixed pain
Baseline (the day that patient sign the informed consent form)
Comorbidities associated with patients
Time Frame: Baseline (the day that patient sign the informed consent form)
Percentage of patients with each comorbidity
Baseline (the day that patient sign the informed consent form)
Change in mean Intensity of breakthrough cancer pain at each study visit
Time Frame: Up to 4 weeks, from date of inclusion until week 4
Intensity of breakthrough cancer pain assessed with a Visual Analog Scale (VAS). VAS will be compared at each study visit.
Up to 4 weeks, from date of inclusion until week 4
Mean time to relief of breakthrough pain
Time Frame: Up to 4 weeks, from date of inclusion until week 4
Time from the start of the episode until the relief of breakthrough pain
Up to 4 weeks, from date of inclusion until week 4
Mean duration of the episodes of breakthrough pain
Time Frame: Up to 4 weeks, from date of inclusion until week 4
Time from the start of the episode until the pain ends
Up to 4 weeks, from date of inclusion until week 4
Patient Global improvement
Time Frame: Week 4
Number of patients indicating each of the possible answers of the Patient Global Impression of improvement scale (7-points Likert scale)
Week 4
Percentage of fragile patients at study entry
Time Frame: Baseline
Frailty of patients will be assessed by Edmonton Symptom Assessment System (ESAS). It is considered that a patient is fragile when the symptom score is greater than 4 (moderate intensity) in five or more symptoms.
Baseline
Cognitive impairment
Time Frame: Baseline
Cognitive impairment (Pfeiffer test): 0-2 errors: intact cognition; 3-4 errors: mild impairment; 5-7 errors: moderate impairment; 8-10 errors: severe impairment. Percentage of patients in each category
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angelini Farmacéutica

Investigators

  • Study Director: Albert Tuca, MD, Hospital Clinic de Barcelona, Palliative Care Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANG-OPI-2016-01 (CAVIDIOPAL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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