Evaluation of ESMO Guidelines Applicability and Adherence in Cancer Pain Management in the Palliative Care Setting

Pain Clinical Trial

Official title:

Evaluation of ESMO Guidelines Applicability and Adherence in Cancer Pain Management in the Specialist Palliative Care Setting: a Multicenter, Perspective, Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04795739
• Other study ID #: PAINSTUDY
• Status: Recruiting
• Start date: January 7, 2021
• Est. completion date: April 7, 2022

Study information

• Verified date: June 2021
• Source: Antea Foundation
• Contact: Chiara Mastroianni
• Phone: +3906303321
• Email: c.mastroianni[@]antea.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 7, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Cancer Pain
• Pain

Locations

Country	Name	City	State
Italy	Hospice Carlo Chenis	Civitavecchia	Roma
Italy	Centro Residenziale di Leniterapia "Roberto Ciabatti"	Grosseto
Italy	Hospice Alba Chiara	Lanciano	Chieti
Italy	Antea Foundation	Roma
Italy	Centro di Cure Palliative "Insieme nella Cura" - Policlinico Universitario - Campus Bio-Medico (Roma)	Roma
Italy	Hospice "La Torre sul Colle"	Spoleto	Perugia
Italy	Fondazione FARO	Torino
Italy	Hospice Torrevecchia Teatina	Torrevecchia Teatina	Chieti

Sponsors (2)

Lead Sponsor	Collaborator
Antea Foundation	Istituto Di Ricerche Farmacologiche Mario Negri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to ESMO (European Society of Medical Oncology) 2018 Guidelines	The assessment of the adherence of pain treatments to the ESMO 2018 guidelines will be carried out assigning to the 52 recommendations a score of 1 if the recommendation has been satisfied on the patient, 0 if it has not been satisfied and missing if the recommendation was not applicable. A total score will then be calculated for each patient, obtained from the sum of the score for each recommendation divided by the number of applicable recommendations. The percentage of adherence to each single recommendation and to the total of recommendations on all patients will also be calculated.	Day 14 (final visit).