Treatment of Breakthrough Cancer Pain According to European Guidelines

NCT04468490 | Terminated

• 1 other identifier: 155(A)WO19191
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breakthrough Cancer Pain

Keywords

Breakthrough cancer pain; Cancer; BTcP; Background pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• APM algorithm

  0, 1, 2, 3, 4 weeks of observation

• Tool-BAT

  at 0, 1, 2, 3, 4 weeks of observation

• EORTC QLQ-C30

  at 0, 1, 2, 3, 4 weeks of observation

• Patient Global Impression of Change (PGIC)

  at 0, 2 and 4 weeks of observation

• Healthcare resources consumed due to cancer pain (Number of specialist/GP visits)

  at 2 and 4 weeks of observation

Study Arms (2)

GROUP A: Patients adherent to BTcP European Guidelines

GROUP B: Patients non Adherent to BTcP European Guidelines

Eligibility Criteria

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

Study Population

The study population includes patients with BTcP.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Nzoz Zespół Medyczno Opiekuńczy Alicja Kluczna

Dąbrowa Górnicza, 41-300, Poland

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 13, 2020
• Study Start: August 11, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)