Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units (CAVIDIOPAL)
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|ClinicalTrials.gov Identifier: NCT02840500|
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : March 5, 2018
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|
|Study Type :||Observational|
|Actual Enrollment :||101 participants|
|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|
Breakthrough Cancer Pain
No intervention (Non-interventional study)
Other: No intervention
- 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.
- 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
- Comorbidities associated with patients [ Time Frame: Baseline (the day that patient sign the informed consent form) ]Percentage of patients with each comorbidity
- 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.
- 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
- 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
- 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)
- 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.
- 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
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
|Hospital de Mollet|
|Mollet del Vallès, Barcelona, Spain, 08100|
|Hospital Sant Joan de Deu|
|Palma, Illes Baleares, Spain, 07007|
|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|
|Study Director:||Albert Tuca, MD||Hospital Clinic de Barcelona, Palliative Care Unit|