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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breakthrough Pain

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breakthrough Cancer Pain<br>No intervention (Non-interventional study) | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life according EORTC QLQ-C30 questionnaire | 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 | Percentage of patients with neuropathic, visceral, somatic and mixed pain | Baseline (the day that patient sign the informed consent form) | 
| Comorbidities associated with patients | 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 | 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 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 from the start of the episode until the pain ends | Up to 4 weeks, from date of inclusion until week 4 | 
| Patient Global improvement | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breakthrough Cancer Pain, Quality of life, Palliative Care Units