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 (part of Angelini Pharma) · 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.
34 studies on the registry are indexed under Breakthrough Pain; 4 are open to participants now.
This study's enrollment of 118 is close to the median of 125 across 10 observational studies indexed under Breakthrough Pain.
Browse Breakthrough Pain studies →Angelini Farmacéutica is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with breakthrough cancer pain treated in Medical Oncology services
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Jan 2020, 25 months.
How these figures are worked out, and which studies are left out of them.
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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