Treatment of Breakthrough Cancer Pain According to European Guidelines (BEG)

Adherence to Breakthrough Cancer Pain (BTcP) European Guidelines: an Observational Prospective Study.

Pain is a frequent symptom in cancer patients with a negative impact on the quality of life (QoL).Breakthrough cancer pain (BTcP) is defined as "a transient exacerbation of pain, manifesting spontaneously or related to a specific predictable or unpredictable triggering factor, despite stable and adequately controlled basal pain". The present study assesses the percentage of patients who are treated according to the European guidelines (ESMO, 2018) for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.

Study Overview

• Status: Terminated
• Conditions: Breakthrough Cancer Pain

Detailed Description

Typical BTcP episodes are of short duration (15-30 minutes/episode), moderate to severe intensity and rapid onset (maximum peak between 3-15 minutes). The best management of BTcP requires a thorough evaluation to tailor the treatment strategies. Indeed, patients with breakthrough pain should have this pain specifically assessed, starting from the appropriate diagnosis. Recently developed European guidelines support this approach and recommend treating BTcP using rapid-onset opioids (ROOs), with pharmacodynamics that mirror the quick start and short duration of the pain episode.Nevertheless, despite the drug treatment for BTcP has undergone knowledge advances in recent years and several guidelines have been published, this condition is still often inadequately managed.

The present study will assess the percentage of patients who are treated according to the European guidelines for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.

• Study Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Poland
  • Dąbrowa Górnicza, Poland, 41-300
    • Nzoz Zespół Medyczno Opiekuńczy Alicja Kluczna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population includes patients with BTcP.

Description

Inclusion Criteria:

• Male and female patients of any ethnic origin of ≥ 18 years.
• Patients diagnosed with locally advanced or recurrent metastatic cancer (histologic or cytologic diagnosis), with BTcP, as assessed by the Investigator.
• Opioid-tolerant patients receiving doses of oral morphine equivalent daily doses (OMEDD) of at least 60 mg.
• Drugs for BTcP treatment, if any, must be used according to the relevant SmPC.
• Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or 2.
• Patients with life expectancy > 3 months.
• Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent.

Exclusion Criteria:

• Patients with previous or current history of a clinically significant neurological/psychiatric disorder and/or any substance abuse or dependence that, according to the Investigator's judgement, can impair the study end-points/results.
• Patients who have been taking antidepressants and/or drugs acting on pain and who take them on a regular basis during the observation period, can be enrolled.
• Any medical condition or situation complicating the collection of study data, as determined by the Investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
GROUP A: Patients adherent to BTcP European Guidelines
GROUP B: Patients non Adherent to BTcP European Guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP.	Percentage of BTcP treatment guideline adherent vs non-adherent patients, in the 4 weeks of observation (V2)	4 weeks of observation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APM algorithm	BTcP diagnosis by APM algorithm observation (V0, telephone contact1, V1, telephone contact2, V2)	0, 1, 2, 3, 4 weeks of observation
Tool-BAT	BTcP assessment by Tool-BAT (V0, telephone contact1, V1, telephone contact2, V2)	at 0, 1, 2, 3, 4 weeks of observation
EORTC QLQ-C30	Quality of life assessed by the questionnaire EORTC: 28 questions from 1 to 4 (there are not wrong or right answers) + 2 questions from 7 point scales from 1 (very poor) to 7 (excellent)	at 0, 1, 2, 3, 4 weeks of observation
Patient Global Impression of Change (PGIC)	Global impression of clinical condition assessed by the Patient through 7 point scales from 1 (very much improved) to 7 (very much worse).	at 0, 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of specialist/GP visits)	Number of specialist/GP visits due to cancer pain during the observation period	at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of hospitalizations)	Number of hospitalizations due to cancer pain during the observation period	at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Length of hospitalizations)	Length of hospitalizations (days) due to cancer pain during the observation period	at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of admittances to ER) due to cancer pain)	Number of admittances to ER due to cancer pain during the observation period	at 2 and 4 weeks of observation

Collaborators and Investigators

• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Breakthrough cancer pain; BTcP; Background pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: 155(A)WO19191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No