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

Completed

• Conditions: Breakthrough Pain
• Interventions: Other: No intervention

• Registration Number: NCT02840500
• Lead Sponsor: Angelini Farmacéutica

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-27
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-21
• Primary Completion: 2017-12
• Status Verified: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breakthrough Cancer Pain	No intervention	No intervention (Non-interventional study)

Primary Outcome Measures

Name	Time	Method
Change in quality of life according EORTC QLQ-C30 questionnaire	Baseline and 4 weeks	Change in punctuation of the EORTC QLQ-C30 questionnaire between week 4 and baseline.

Secondary Outcome Measures

Name	Time	Method
Patient Global improvement	Week 4	Number of patients indicating each of the possible answers of the Patient Global Impression of improvement scale (7-points Likert scale)
Change in mean Intensity of breakthrough cancer pain at each study visit	Up to 4 weeks, from date of inclusion until week 4	Intensity of breakthrough cancer pain assessed with a Visual Analog Scale (VAS). VAS will be compared at each study visit.
Mean time to relief of breakthrough pain	Up to 4 weeks, from date of inclusion until week 4	Time from the start of the episode until the relief of breakthrough pain
Mean duration of the episodes of breakthrough pain	Up to 4 weeks, from date of inclusion until week 4	Time from the start of the episode until the pain ends
Percentage of fragile patients at study entry	Baseline	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.
Comorbidities associated with patients	Baseline (the day that patient sign the informed consent form)	Percentage of patients with each comorbidity
Percentage of patients with neuropathic, visceral, somatic and mixed pain	Baseline (the day that patient sign the informed consent form)	Percentage of patients with neuropathic, visceral, somatic and mixed pain
Cognitive impairment	Baseline	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

Trial Locations

Locations (10)

Hospital de Mollet; 🇪🇸 Mollet del Vallès, Barcelona, Spain

Hospital Sant Joan de Deu; 🇪🇸 Palma, Illes Baleares, Spain

Hospital Clínic; 🇪🇸 Barcelona, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Complejo Hospitalario de Ourense; 🇪🇸 Ourense, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain