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

Breakthrough Pain Clinical Trial

— CAVIDIOPAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840500
• Other study ID #: ANG-OPI-2016-01 (CAVIDIOPAL)
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: March 2, 2018
• Start date: June 27, 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Angelini Farmacéutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breakthrough Pain

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital Arnau de Vilanova	Lleida
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital de Mollet	Mollet del Vallès	Barcelona
Spain	Complejo Hospitalario de Ourense	Ourense
Spain	Hospital Sant Joan de Deu	Palma	Illes Baleares
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital Virgen de la Salud	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Angelini Farmacéutica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life according EORTC QLQ-C30 questionnaire	Change in punctuation of the EORTC QLQ-C30 questionnaire between week 4 and baseline.	Baseline and 4 weeks
Secondary	Percentage of patients with neuropathic, visceral, somatic and mixed pain	Percentage of patients with neuropathic, visceral, somatic and mixed pain	Baseline (the day that patient sign the informed consent form)
Secondary	Comorbidities associated with patients	Percentage of patients with each comorbidity	Baseline (the day that patient sign the informed consent form)
Secondary	Change in mean Intensity of breakthrough cancer pain at each study visit	Intensity of breakthrough cancer pain assessed with a Visual Analog Scale (VAS). VAS will be compared at each study visit.	Up to 4 weeks, from date of inclusion until week 4
Secondary	Mean time to relief of breakthrough pain	Time from the start of the episode until the relief of breakthrough pain	Up to 4 weeks, from date of inclusion until week 4
Secondary	Mean duration of the episodes of breakthrough pain	Time from the start of the episode until the pain ends	Up to 4 weeks, from date of inclusion until week 4
Secondary	Patient Global improvement	Number of patients indicating each of the possible answers of the Patient Global Impression of improvement scale (7-points Likert scale)	Week 4
Secondary	Percentage of fragile patients at study entry	Frailty of patients will be assessed by Edmonton Symptom Assessment System (ESAS). It is considered that a patient is fragile when the symptom score is greater than 4 (moderate intensity) in five or more symptoms.	Baseline
Secondary	Cognitive impairment	Cognitive impairment (Pfeiffer test): 0-2 errors: intact cognition; 3-4 errors: mild impairment; 5-7 errors: moderate impairment; 8-10 errors: severe impairment. Percentage of patients in each category	Baseline