An observational study in Breakthrough Pain, sponsored by Angelini Farmacéutica. Completed at 14 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-02.
Sponsored by Angelini Farmacéutica · Observational
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.
Patients with breakthrough cancer pain treated in Medical Oncology services
Exclusion Criteria:
No intervention (Non Interventional Study)
Other: No intervention
No intervention
Changes in quality of life of the patients
Changes according to EQ-5D-5L questionnaire
Time frame: Up to 4 weeks
Characteristics of patients
Kind of tumor.
Time frame: At baseline
Characteristics of patients
Demographic data
Time frame: At baseline
Characteristics of patients
ECOG
Time frame: At baseline
Management of cancer breakthrough pain.
Cancer breakthrough pain characteristics (time until maximum intensity)
Time frame: Up to 4 weeks
Management of cancer breakthrough pain.
Cancer breakthrough pain evolution (duration and management)
Time frame: Up to 4 weeks
Anxiety and depression status and the possible relationship between these factors and quality of life.
Goldberg Anxiety and Depression Scale.
Time frame: Up to 4 weeks
Sleep quality and the possible relationship between this factor and quality of life.
MOS sleep questionnaire
Time frame: Up to 4 weeks
Evaluate caregivers effort
Results according to caregivers effort Index
Time frame: Up to 4 weeks
Perceived assistance quality by patients
Results according to Sociofamily evaluation scale of "Gijon"
Time frame: 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)
Time frame: Up to 4 weeks
Improvement impression perceived by patients
Results according to Satisfaction questionnaire PGI-I
Time frame: Up to 4 weeks
Improvement impression perceived by patients
Results according to Satisfaction questionnaire CGI-I
Time frame: Up to 4 weeks
Plan to share: No
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Angelini Farmacéutica