Clinical trial NCT02840500: Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units
Official title: Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breakthrough Pain
Keywords: Breakthrough Cancer Pain
Quality of life
Palliative Care Units
Lead sponsor: Angelini Farmacéutica
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breakthrough cancer pain attended in Palliative Care Units will be included

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in quality of life according EORTC QLQ-C30 questionnaire
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Percentage of patients with neuropathic, visceral, somatic and mixed pain
timeFrame: Baseline (the day that patient sign the informed consent form)
measure: Comorbidities associated with patients
timeFrame: Baseline (the day that patient sign the informed consent form)
measure: Change in mean Intensity of breakthrough cancer pain at each study visit
timeFrame: Up to 4 weeks, from date of inclusion until week 4
measure: Mean time to relief of breakthrough pain
timeFrame: Up to 4 weeks, from date of inclusion until week 4
measure: Mean duration of the episodes of breakthrough pain
timeFrame: Up to 4 weeks, from date of inclusion until week 4
measure: Patient Global improvement
timeFrame: Week 4
measure: Percentage of fragile patients at study entry
timeFrame: Baseline
measure: Cognitive impairment
timeFrame: Baseline
Other outcomes:
Locations:
city: Mollet del Vallès
country: Spain
facility: Hospital de Mollet
state: Barcelona
city: Palma
country: Spain
facility: Hospital Sant Joan de Deu
state: Illes Baleares
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Ourense
country: Spain
facility: Complejo Hospitalario de Ourense
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
Study officials:
affiliation: Hospital Clinic de Barcelona, Palliative Care Unit
name: Albert Tuca, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.