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 Type
OBSERVATIONAL
Enrollment
101
No intervention
Hospital de Mollet
Mollet del Vallès, Barcelona, Spain
Hospital Sant Joan de Deu
Palma, Illes Baleares, Spain
Hospital Clínic
Barcelona, Spain
Hospital Virgen de las Nieves
Granada, Spain
Hospital Arnau de Vilanova
Lleida, Spain
Hospital Gregorio Marañón
Madrid, Spain
Fundación Jiménez Díaz
Madrid, Spain
Complejo Hospitalario de Ourense
Ourense, Spain
Hospital Virgen del Rocío
Seville, Spain
Hospital Virgen de la Salud
Toledo, Spain
Change in quality of life according EORTC QLQ-C30 questionnaire
Change in punctuation of the EORTC QLQ-C30 questionnaire between week 4 and baseline.
Time frame: Baseline and 4 weeks
Percentage of patients with neuropathic, visceral, somatic and mixed pain
Percentage of patients with neuropathic, visceral, somatic and mixed pain
Time frame: Baseline (the day that patient sign the informed consent form)
Comorbidities associated with patients
Percentage of patients with each comorbidity
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: Baseline
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