Clinical trial NCT04142567: Role of the Pharmacist in Detection of Drug Interactions Before Antitumor Treatment Initiation
Official title: Role of the Clinical Pharmacist in an Oncology Ambulatory Center to Prevent Drug Related Problems Before Antitumor Treatment Initiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm
Keywords: Drug drug interactions
Pharmacist interventions
Cancer patients
Out patient setting
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients in outpatient setting, treated in two Paris hospitals

Brief summary: 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

Detailed description: 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

* The detection of drug drug interactions with theriaque software, Micromedex software and DDI predictor tool.
* The clinical gradation by an independent expert comity of the clinical impact of avoided drug drug interaction. The expert comity will grade avoided clinical consequences in 3 levels (minor, moderate or major),
* The Economic evaluation of pharmacist intervention: Cost of the project to evaluate drug drug interaction and benefits after evaluation of avoided clinical consequences
* The Adherence evaluation of patients treated with oral cancer targeted therapy (Therefore, only patients under oral targeted therapy will be evaluated at Day0, Day15 ,Day 30 and Month 6 to determine adherence.)

Eligibility criteria: Inclusion Criteria:

* legal age patients
* Affiliated to social security or with another insurance system
* with a solid tumor
* who are going to receive an antitumor treatment (chemotherapy, immunotherapy or oral targeted therapy)

Exclusion Criteria:

* pregnant women
* minor patient

Primary outcomes:
measure: Prevalence of Pharmacist intervention
timeFrame: up to 1 week from date of inclusion
Secondary outcomes:
measure: Detection of Drug -drug interactions
timeFrame: up to 1 week from date of inclusion
measure: Clinical gradation of drug drug interactions
timeFrame: One year
measure: Cost of the pharmacist intervention by avoided clinical consequence
timeFrame: One year
measure: Potential cost of the avoided clinical consequences
timeFrame: One year
measure: Adherence evaluation with oral cancer targeted therapy by therapeutic drug monitoring
timeFrame: day 15, 30 and 6 months after oral therapy initiation
measure: Adherence evaluation with oral cancer targeted therapy by the 6 item-Girerd Scale
timeFrame: day 15, 30 and 6 months after oral therapy initiation
measure: Adherence evaluation with oral cancer targeted therapy by pill count
timeFrame: 6 months after oral therapy initiation
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP -Cochin Hospital and Georges Pompidou European Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Audrey Thomas-Schoemann, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.