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NCT Number: NCT02840500

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

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.

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Key information

Conditions

Breakthrough Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Mollet, Mollet del Vallès, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Angelini Farmacéutica

Industry

Registry information

Acronym: CAVIDIOPAL

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 21, 2016
Registry last updated
Mar 5, 2018

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

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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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