Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units (CAVIDIOPAL)

Angelini Pharma

Status: Completed

Conditions: Breakthrough Pain

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02840500

ANG-OPI-2016-01 (CAVIDIOPAL)

Details and patient eligibility

About

Patients treated in Palliative Care Units are potentially fragile patients, especially in our case, which are cancer patients. The management of these patients is usually done from experience, because these patients rarely meet criteria for clinical trials, as their inclusion could affect results obtained in the trial.

There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in palliative care units according to routine clinical practice. For this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain treated in palliative care units as well as the characteristics of these patients.

This post-authorization observational study will assess the quality of life of patients with breakthrough cancer pain treated in Palliative Care Units in Spanish hospitals.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients > 18 years
• Patients with advanced cancer
• Patients attended in Palliative Care Units
• Life expectancy> 3 months
• Written informed consent
• Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm

Exclusion criteria

• Serious psychiatric disorder, cognitive impairment or any disease or condition that prevents the collection of data
• Patients with evidence of opioid addiction or history of drug or alcohol abuse

Trial design

101 participants in 1 patient group

Breakthrough Cancer Pain

Description:

No intervention (Non-interventional study)

Treatment:

Other: No intervention