APHP -Cochin Hospital and Georges Pompidou European Hospital
Paris, 75014, France
NCT Number: NCT04142567
The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.
The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases. The primary endpoint is the prevalence of pharmacist interventions among patients who are going to receive an oral targeted therapy or cancer chemotherapy or immunotherapy
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Notify MeThe purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.
The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases.
The primary endpoint is the prevalence of pharmacist interventions among cancer patients who are going to receive an oral targeted therapy (140 patients) or cancer chemotherapy or immunotherapy (300 patients).
Pharmacist interventions will be classified according to the SFPC (société française de pharmacie Clinique) classification.
The secondary endpoints are
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 1 week from date of inclusion
Percentage of patients whom antitumora treatment or usual treatment has been changed by the pharmacist intervention
Time frame: up to 1 week from date of inclusion
Number of drug drug interactions detected
Time frame: One year
Gradation by an independent experts comity of the clinical impact of prevented drug drug interaction
Time frame: One year
Cost evaluation of pharmacist for analysis and medication review with patient by avoided interaction
Time frame: One year
Treatment cost of avoided clinical consequences , balanced with the probability of occurrence
Time frame: day 15, 30 and 6 months after oral therapy initiation
Patients with plasma drug concentration below the 10th percentile will be classified as nonadherent patients
Time frame: day 15, 30 and 6 months after oral therapy initiation
Patients with a Girerd score greater than or equal to 3 will be classified as nonadherent patients
Time frame: 6 months after oral therapy initiation
Pill counts will be used to calculate the percent of total prescribed dose taken to prescribed during the 90-day period
Assistance Publique - Hôpitaux de Paris
Other
Role of the Clinical Pharmacist in an Oncology Ambulatory Center to Prevent Drug Related Problems Before Antitumor Treatment Initiation
Acronym: CHOPIN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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