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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-07

Study Completion Date

2022-04-07

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Pain Pain Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Di Ricerche Farmacologiche Mario Negri

OTHER

Sponsor Role collaborator

Antea Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuseppe Casale

Role: PRINCIPAL_INVESTIGATOR

Antea Foundation

Locations

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Hospice Alba Chiara

Lanciano, Chieti, Italy

Site Status RECRUITING

Hospice Torrevecchia Teatina

Torrevecchia Teatina, Chieti, Italy

Site Status RECRUITING

Hospice "La Torre sul Colle"

Spoleto, Perugia, Italy

Site Status RECRUITING

Hospice Carlo Chenis

Civitavecchia, Roma, Italy

Site Status RECRUITING

Centro Residenziale di Leniterapia "Roberto Ciabatti"

Grosseto, , Italy

Site Status NOT_YET_RECRUITING

Antea Foundation

Roma, , Italy

Site Status RECRUITING

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

Roma, , Italy

Site Status RECRUITING

Fondazione FARO

Torino, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Chiara Mastroianni

Role: CONTACT

+3906303321

Facility Contacts

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Pier Paolo Carinci

Role: primary

Pier Paolo Carinci

Role: primary

Marta De Angelis

Role: primary

Mario Rosario D'Andrea

Role: primary

Giuseppe Casale

Role: primary

Grazia Armento

Role: primary

Alessandro Valle

Role: primary

Other Identifiers

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PAINSTUDY

Identifier Type: -

Identifier Source: org_study_id

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