Cancer PainNCT04795739
Evaluation of ESMO Guidelines Applicability and Adherence in Cancer Pain Management in the Palliative Care Setting
An observational study of Cancer Pain and Pain, run by Antea Foundation at 8 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Pain, Cancer
- How many people
- 500 participants
- Where
- 8 sitesItaly
- Study dates
- 7 Jan 2021to 7 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients with pain in palliative care setting.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites, 8 recruiting
- Recruiting
Hospice Carlo Chenis
Civitavecchia, Roma
Mario Rosario D'Andrea, mariorosario.dandrea@aslroma4.it
- Not yet recruiting
Centro Residenziale di Leniterapia "Roberto Ciabatti"
Grosseto
- Recruiting
Hospice Alba Chiara
Lanciano, Chieti
Pier Paolo Carinci, pierpaolo.carinci@asl2abruzzo.it
- Recruiting
Antea Foundation
Roma, 00135
Giuseppe Casale, 06303321, research@antea.net
- Recruiting
Centro di Cure Palliative "Insieme nella Cura" - Policlinico Universitario - Campus Bio-Medico (Roma)
Roma
Grazia Armento, G.Armento@unicampus.it
- Recruiting
Hospice "La Torre sul Colle"
Spoleto, Perugia
Marta De Angelis, emmedea@gmail.com
- Recruiting
Fondazione FARO
Torino
Alessandro Valle, alessandro.valle@fondazionefaro.it
- Recruiting
Hospice Torrevecchia Teatina
Torrevecchia Teatina, Chieti
Pier Paolo Carinci, pierpaolo.carinci@asl2abruzzo.it
About this study
Official title: Evaluation of ESMO Guidelines Applicability and Adherence in Cancer Pain Management in the Specialist Palliative Care Setting: a Multicenter, Perspective, Observational Study
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%.
Read more
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
- Medical subject headings
- Cancer Pain, Pain, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14 (final visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start7 Jan 2021
- Primary completion7 Apr 2022 (estimated)
- Study completion7 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antea Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri
- Responsible party
- Sponsor
- Investigators
- Giuseppe Casale, Principal investigator, Antea Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795739
- Sponsor's protocol ID
- PAINSTUDY
- Status last verified
- Jun 2021
- First submitted
- 17 Feb 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ESMO Guidelines Applicability and Adherence in Cancer Pain Management in the Specialist Palliative Care Setting: a Multicenter, Perspective, Observational Study
- ClinicalTrials.gov ID
- NCT04795739
- Acronym / sponsor ID
- PAINSTUDY
- Conditions
- Cancer Pain, Pain, Cancer
- Keywords
- Palliative care, Pain, Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Antea FoundationUniversity, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 7 Apr 2022 (estimated)
- Study completion
- 7 Apr 2022 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with pain in palliative care setting.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to ESMO (European Society of Medical Oncology) 2018 Guidelines
Time frame: Day 14 (final visit).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Casale principal investigator
Antea Foundation
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Pain and Pain, run by Antea Foundation at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiara Mastroianni (+3906303321, c.mastroianni@antea.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to ESMO (European Society of Medical Oncology) 2018 Guidelines (time frame: Day 14 (final visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.