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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03512-53 | Other Identifier | Eudract |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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
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 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
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Pharmacist intervention | Percentage of patients whom antitumora treatment or usual treatment has been changed by the pharmacist intervention | up to 1 week from date of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Drug -drug interactions | Number of drug drug interactions detected | up to 1 week from date of inclusion |
| Clinical gradation of drug drug interactions | Gradation by an independent experts comity of the clinical impact of prevented drug drug interaction |
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Inclusion Criteria:
Exclusion Criteria:
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Cancer patients in outpatient setting, treated in two Paris hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Audrey Thomas-Schoemann, PharmD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHP -Cochin Hospital and Georges Pompidou European Hospital | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24041628 | Background | Thomas-Schoemann A, Blanchet B, Bardin C, Noe G, Boudou-Rouquette P, Vidal M, Goldwasser F. Drug interactions with solid tumour-targeted therapies. Crit Rev Oncol Hematol. 2014 Jan;89(1):179-96. doi: 10.1016/j.critrevonc.2013.08.007. Epub 2013 Aug 28. | |
| Background | P. Boudou Rouquette, A. Thomas-Schoemann, A. Chahwakilian et al., Clinical benefit of a one-day multidisciplinary work-up for risk assessment in unfit cancer patients. ESMO congress, abstract 1558; Amsterdam 2013 | ||
| 28361167 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| One year |
| Cost of the pharmacist intervention by avoided clinical consequence | Cost evaluation of pharmacist for analysis and medication review with patient by avoided interaction | One year |
| Potential cost of the avoided clinical consequences | Treatment cost of avoided clinical consequences , balanced with the probability of occurrence | One year |
| Adherence evaluation with oral cancer targeted therapy by therapeutic drug monitoring | Patients with plasma drug concentration below the 10th percentile will be classified as nonadherent patients | day 15, 30 and 6 months after oral therapy initiation |
| Adherence evaluation with oral cancer targeted therapy by the 6 item-Girerd Scale | Patients with a Girerd score greater than or equal to 3 will be classified as nonadherent patients | day 15, 30 and 6 months after oral therapy initiation |
| Adherence evaluation with oral cancer targeted therapy by pill count | Pill counts will be used to calculate the percent of total prescribed dose taken to prescribed during the 90-day period | 6 months after oral therapy initiation |
| Background |
| Bonnet C, Boudou-Rouquette P, Azoulay-Rutman E, Huillard O, Golmard JL, Carton E, Noe G, Vidal M, Orvoen G, Chah Wakilian A, Villeminey C, Blanchet B, Alexandre J, Goldwasser F, Thomas-Schoemann A. Potential drug-drug interactions with abiraterone in metastatic castration-resistant prostate cancer patients: a prevalence study in France. Cancer Chemother Pharmacol. 2017 May;79(5):1051-1055. doi: 10.1007/s00280-017-3291-z. Epub 2017 Mar 30. |
| 21741307 | Background | Lees J, Chan A. Polypharmacy in elderly patients with cancer: clinical implications and management. Lancet Oncol. 2011 Dec;12(13):1249-57. doi: 10.1016/S1470-2045(11)70040-7. Epub 2011 Jul 6. |
| 17440160 | Background | Riechelmann RP, Tannock IF, Wang L, Saad ED, Taback NA, Krzyzanowska MK. Potential drug interactions and duplicate prescriptions among cancer patients. J Natl Cancer Inst. 2007 Apr 18;99(8):592-600. doi: 10.1093/jnci/djk130. |
| 19147869 | Background | Ruddy K, Mayer E, Partridge A. Patient adherence and persistence with oral anticancer treatment. CA Cancer J Clin. 2009 Jan-Feb;59(1):56-66. doi: 10.3322/caac.20004. |
| 39403043 | Result | Giraud JS, Korb-Savoldelli V, Perrin G, Jouinot A, Sabatier B, Batista R, Ribault M, De Percin S, Villeminey C, Videau M, Blanchet B, Goldwasser F, Degrassat-Theas A, Thomas-Schoemann A. Clinical and economic impact of pharmacist interventions to identify drug-related problems in multidisciplinary cancer care: a prospective trial. Oncologist. 2025 Aug 4;30(8):oyae213. doi: 10.1093/oncolo/oyae213. |