Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breakthrough Pain
- Sponsor
- Angelini Farmacéutica
- Enrollment
- 118
- Locations
- 14
- Primary Endpoint
- Changes in quality of life of the patients
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
In cancer patients, pain is one of the most common symptoms. The range of reported prevalence of pain varies from 33% to 64% including different stages of cancer, during or after anticancer treatment. Moreover, despite the optimal management of basal chronic pain, 66% of these patients have reported breakthrough pain which has a severe impact on quality of life. There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in medical oncology services 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 in medical oncology services as well as other factors that can affect quality of life. This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in medical oncology services in Spanish hospitals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients \> 18 years
- •Patients with histologically confirmed neoplasia
- •Patients attended in medical oncology consultations
- •Life expectancy \> 3 months
- •Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm
- •Written informed consent
Exclusion Criteria
- •Untreated patients with opioids for baseline pain
- •Patients who are not opioid tolerant
- •Serious psychiatric disorder or any disease or condition that prevents the collection of data
- •Patients with evidence of opioid addiction or history of drug or alcohol abuse
Outcomes
Primary Outcomes
Changes in quality of life of the patients
Time Frame: Up to 4 weeks
Changes according to EQ-5D-5L questionnaire
Secondary Outcomes
- Characteristics of patients(At baseline)
- Management of cancer breakthrough pain.(Up to 4 weeks)
- Anxiety and depression status and the possible relationship between these factors and quality of life.(Up to 4 weeks)
- Sleep quality and the possible relationship between this factor and quality of life.(Up to 4 weeks)
- Evaluate caregivers effort(Up to 4 weeks)
- Perceived assistance quality by patients(Up to 4 weeks)
- Improvement impression perceived by patients(Up to 4 weeks)