Clinical trial NCT04795739: Evaluation of ESMO Guidelines Applicability and Adherence in Cancer Pain Management in the Palliative Care Setting
Official title: Evaluation of ESMO Guidelines Applicability and Adherence in Cancer Pain Management in the Specialist Palliative Care Setting: a Multicenter, Perspective, Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Pain
Pain
Cancer
Keywords: Palliative care
Pain
Cancer
Lead sponsor: Antea Foundation
Sponsor class: OTHER
Collaborators: name: Istituto Di Ricerche Farmacologiche Mario Negri
First posted: 2021-03-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients with pain in palliative care setting.

Brief summary: Palliative care (PC) is focused on improving the Quality of Life (QoL) of patients living with a life-threatening illness. Each year, an estimated 40 million people need PC management in the world. In the European Union, it is estimated that about 4,5 million of people are in the need of PC every year, with about 40% affected by malignant neoplasia.

Data from a recent systematic review of the literature report that the prevalence of pain is 66% (95% confidence interval 58-75) in cancer patients with advanced stages of the disease. In 52% of cases, pain was moderate or severe in intensity (NRS, Numeric Rating Scale ≥4). Furthermore, in addition to the basic pain, having characteristics of continuity over time even in the presence of fluctuations in intensity, the presence of acute painful episodes must also be considered, which are defined with the term of Breakthrough Cancer Pain, (BTcP), whose prevalence is estimated between 21 and 59%.

The positive impact on the quality of life of cancer patients of adhering to current guidelines has been amply demonstrated. Recently, new guidelines or recommendations produced by scientific societies have published, including the European Association of Palliative Care, the National Comprehensive Cancer Network and the European Society for Medical Oncology (ESMO).

In clinical facilities directly involved in the treatment of pain in cancer patients, implementing the directives set out in the guidelines appears to be a correct objective for the appropriateness of treatments. Nevertheless, there are no studies in Europe that have evaluated the applicability and adherence to guidelines in the treatment of cancer pain in advanced cancer patients. The present study intends to collect detailed information on the characteristics of pain and the treatment in a population of cancer patients cared by a network of specialized palliative care centers in order to assess the applicability and adherence of the latest European guidelines published by ESMO in 2018 for the treatment of pain in the specific area.


Eligibility criteria: Inclusion Criteria:

* age \>18 years;
* cancer diagnosis;
* patient enrolled within 48h from admission in PC;
* presence of pain with or without analgesic therapy or absence of pain being already on ATC analgesic therapy;
* life expectancy longer than two weeks;
* written patient informed consent.

Exclusion Criteria:

* diagnosis of primary brain tumor or leukemia (acute or chronic);
* clinical conditions that, at Investigator evaluation, prevent the follow up visits;
* absence of pain without analgesic therapy.

Primary outcomes:
measure: Adherence to ESMO (European Society of Medical Oncology) 2018 Guidelines
timeFrame: Day 14 (final visit).
Secondary outcomes:
Other outcomes:
Locations:
city: Lanciano
country: Italy
facility: Hospice Alba Chiara
state: Chieti
city: Torrevecchia Teatina
country: Italy
facility: Hospice Torrevecchia Teatina
state: Chieti
city: Spoleto
country: Italy
facility: Hospice "La Torre sul Colle"
state: Perugia
city: Civitavecchia
country: Italy
facility: Hospice Carlo Chenis
state: Roma
city: Grosseto
country: Italy
facility: Centro Residenziale di Leniterapia "Roberto Ciabatti"
city: Roma
country: Italy
facility: Antea Foundation
city: Roma
country: Italy
facility: Centro di Cure Palliative "Insieme nella Cura" - Policlinico Universitario - Campus Bio-Medico (Roma)
city: Torino
country: Italy
facility: Fondazione FARO
Study officials:
affiliation: Antea Foundation
name: Giuseppe Casale
role: PRINCIPAL_INVESTIGATOR
References: