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

NCT04795739 | Unknown

• 1 other identifier: PAINSTUDY
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 8

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.

Conditions

Cancer Pain; Pain; Cancer

Keywords

Palliative care; Pain; Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cancer patients with pain in palliative care setting.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antea Foundation: lead
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator

Study Sites (8)

Hospice Alba Chiara

Lanciano, Chieti, Italy

RECRUITING

Hospice Torrevecchia Teatina

Torrevecchia Teatina, Chieti, Italy

RECRUITING

Hospice "La Torre sul Colle"

Spoleto, Perugia, Italy

RECRUITING

Hospice Carlo Chenis

Civitavecchia, Roma, Italy

RECRUITING

Centro Residenziale di Leniterapia "Roberto Ciabatti"

Grosseto, Italy

NOT YET RECRUITING

Antea Foundation

Roma, 00135, Italy

RECRUITING

Centro di Cure Palliative "Insieme nella Cura" - Policlinico Universitario - Campus Bio-Medico (Roma)

Roma, Italy

RECRUITING

Fondazione FARO

Torino, Italy

RECRUITING

MeSH Terms

Conditions

Cancer Pain; Pain; Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Casale

  Antea Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Mastroianni

CONTACT

+3906303321; c.mastroianni@antea.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 12, 2021
• Study Start: January 7, 2021
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

IT (8)