Quality of Life Study Breakthrough Cancer Pain Treated in Medical Oncology Services (CAVIDIOM)

Study Overview
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Brief Summary
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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.

Official Title
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Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Medical Oncology Services

Conditions
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Breakthrough Pain

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breakthrough Cancer Pain<br>No intervention (Non Interventional Study) | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality of life of the patients | Changes according to EQ-5D-5L questionnaire | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of patients | Kind of tumor. | At baseline | 
| Characteristics of patients | Demographic data | At baseline | 
| Characteristics of patients | ECOG | At baseline | 
| Management of cancer breakthrough pain. | Cancer breakthrough pain characteristics (time until maximum intensity) | Up to 4 weeks | 
| Management of cancer breakthrough pain. | Cancer breakthrough pain evolution (duration and management) | Up to 4 weeks | 
| Anxiety and depression status and the possible relationship between these factors and quality of life. | Goldberg Anxiety and Depression Scale. | Up to 4 weeks | 
| Sleep quality and the possible relationship between this factor and quality of life. | MOS sleep questionnaire | Up to 4 weeks | 
| Evaluate caregivers effort | Results according to caregivers effort Index | Up to 4 weeks | 
| Perceived assistance quality by patients | Results according to Sociofamily evaluation scale of Gijon | Up to 4 weeks | 
| Improvement impression perceived by patients | Results according to assessment of perceived quality (questionnaire of the Ministry of Health and Consumer Affairs) | Up to 4 weeks | 
| Improvement impression perceived by patients | Results according to Satisfaction questionnaire PGI-I | Up to 4 weeks | 
| Improvement impression perceived by patients | Results according to Satisfaction questionnaire CGI-I | Up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breakthrough Cancer Pain, Quality of life, Medical Oncology