Breakthrough Pain
Conditions
Keywords
Breakthrough Cancer Pain, Quality of life, Medical Oncology
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Apices Soluciones S.L.
Angelini Farmacéutica
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in quality of life of the patients | Up to 4 weeks | Changes according to EQ-5D-5L questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Management of cancer breakthrough pain. | Up to 4 weeks | Cancer breakthrough pain characteristics (time until maximum intensity) |
| Anxiety and depression status and the possible relationship between these factors and quality of life. | Up to 4 weeks | Goldberg Anxiety and Depression Scale. |
| Sleep quality and the possible relationship between this factor and quality of life. | Up to 4 weeks | MOS sleep questionnaire |
| Characteristics of patients | At baseline | Kind of tumor. |
| Perceived assistance quality by patients | Up to 4 weeks | Results according to Sociofamily evaluation scale of Gijon |
| Improvement impression perceived by patients | Up to 4 weeks | Results according to assessment of perceived quality (questionnaire of the Ministry of Health and Consumer Affairs) |
| Evaluate caregivers effort | Up to 4 weeks | Results according to caregivers effort Index |
Countries
Spain
Outcome results
None listed