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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breakthrough Cancer Pain | No intervention (Non-interventional study) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with breakthrough cancer pain attended in Palliative Care Units will be included
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| Name | Affiliation | Role |
|---|---|---|
| Albert Tuca, MD | Hospital Clinic de Barcelona, Palliative Care Unit | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Mollet | Mollet del Vallès | Barcelona | 08100 | Spain | ||
| Hospital Sant Joan de Deu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35137627 | Derived | Rodriguez AT, Viejo MN, Maradey P, Canal-Sotelo J, Mancilla PG, Rivero SG, Casillas IR, Abian MH, Bermudo CL. Low-dose sublingual fentanyl improves quality of life in patients with breakthrough cancer pain in palliative care. Future Oncol. 2022 May;18(14):1717-1731. doi: 10.2217/fon-2021-1639. Epub 2022 Feb 9. | |
| 33533986 | Derived |
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| ID | Term |
|---|---|
| D059390 | Breakthrough Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| Palma |
| Illes Baleares |
| 07007 |
| Spain |
| Hospital Clínic | Barcelona | 08036 | Spain |
| Hospital Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Arnau de Vilanova | Lleida | 25198 | Spain |
| Hospital Gregorio Marañón | Madrid | 28007 | Spain |
| Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Complejo Hospitalario de Ourense | Ourense | 32005 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Virgen de la Salud | Toledo | 45005 | Spain |
| Tuca Rodriguez A, Nunez Viejo M, Maradey P, Canal-Sotelo J, Guardia Mancilla P, Gutierrez Rivero S, Raja Casillas I, Herrera Abian M, Lopez Bermudo C. Impact of individualized management of breakthrough cancer pain on quality of life in advanced cancer patients: CAVIDIOPAL study. Support Care Cancer. 2021 Aug;29(8):4799-4807. doi: 10.1007/s00520-021-06006-1. Epub 2021 Feb 3. |