Evaluation of ESMO Guidelines Applicability and Adherence in Cancer Pain Management in the Palliative Care Setting
NCT ID: NCT04795739
Last Updated: 2021-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2021-01-07
2022-04-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* clinical conditions that, at Investigator evaluation, prevent the follow up visits;
* absence of pain without analgesic therapy.
18 Years
ALL
No
Sponsors
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Istituto Di Ricerche Farmacologiche Mario Negri
OTHER
Antea Foundation
OTHER
Responsible Party
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Principal Investigators
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Giuseppe Casale
Role: PRINCIPAL_INVESTIGATOR
Antea Foundation
Locations
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Hospice Alba Chiara
Lanciano, Chieti, Italy
Hospice Torrevecchia Teatina
Torrevecchia Teatina, Chieti, Italy
Hospice "La Torre sul Colle"
Spoleto, Perugia, Italy
Hospice Carlo Chenis
Civitavecchia, Roma, Italy
Centro Residenziale di Leniterapia "Roberto Ciabatti"
Grosseto, , Italy
Antea Foundation
Roma, , Italy
Centro di Cure Palliative "Insieme nella Cura" - Policlinico Universitario - Campus Bio-Medico (Roma)
Roma, , Italy
Fondazione FARO
Torino, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PAINSTUDY
Identifier Type: -
Identifier Source: org_study_id
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