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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840500
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Angelini Farmacéutica

Brief Summary:

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.


Condition or disease Intervention/treatment
Breakthrough Pain Other: No intervention

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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units
Actual Study Start Date : June 27, 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Comorbidities associated with patients [ Time Frame: Baseline (the day that patient sign the informed consent form) ]
    Percentage of patients with each comorbidity

  3. 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.

  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

  5. 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

  6. 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)

  7. 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.

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with breakthrough cancer pain attended in Palliative Care Units will be included
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840500


Locations
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Spain
Hospital de Mollet
Mollet del Vallès, Barcelona, Spain, 08100
Hospital Sant Joan de Deu
Palma, Illes Baleares, Spain, 07007
Hospital Clínic
Barcelona, Spain, 08036
Hospital Virgen de las Nieves
Granada, Spain, 18014
Hospital Arnau de Vilanova
Lleida, Spain, 25198
Hospital Gregorio Marañón
Madrid, Spain, 28007
Fundación Jiménez Díaz
Madrid, Spain, 28040
Complejo Hospitalario de Ourense
Ourense, Spain, 32005
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Hospital Virgen de la Salud
Toledo, Spain, 45005
Sponsors and Collaborators
Angelini Farmacéutica
Investigators
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Study Director: Albert Tuca, MD Hospital Clinic de Barcelona, Palliative Care Unit
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Responsible Party: Angelini Farmacéutica
ClinicalTrials.gov Identifier: NCT02840500    
Other Study ID Numbers: ANG-OPI-2016-01 (CAVIDIOPAL)
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Angelini Farmacéutica:
Breakthrough Cancer Pain
Quality of life
Palliative Care Units
Additional relevant MeSH terms:
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Breakthrough Pain
Pain
Neurologic Manifestations