An observational study in Breakthrough Pain, sponsored by Angelini Farmacéutica. Completed at 10 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by Angelini Farmacéutica (part of Angelini Pharma) · Observational
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.
34 studies on the registry are indexed under Breakthrough Pain; 4 are open to participants now.
This study's enrollment of 101 is below the median of 125 across 10 observational studies indexed under Breakthrough Pain.
Browse Breakthrough Pain studies →Angelini Farmacéutica is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with breakthrough cancer pain attended in Palliative Care Units will be included
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention (Non-interventional study)
Other: No intervention
No intervention
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
Plan to share: No
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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