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JOURNAL ONKOLOGIE – STUDIE
OpTAT

Optimization of the Targeted Anticancer Therapies

Rekrutierend

NCT-Nummer:
NCT04484064

Studienbeginn:
Mai 2015

Letztes Update:
23.07.2020

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Centre Hospitalier Universitaire Vaudois

Collaborator:
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, Krebsforschung Schweiz, Bern, Switzerland,

Studienleiter

Chantal Csajka, PharmD, PhD
Principal Investigator
Clinical Pharmacy Sciences

Kontakt

Chantal Csajka, PharmD, PhD
Kontakt:
Phone: 21 314 42 63
Phone (ext.): +41
E-Mail: chantal.csajka@chuv.ch
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Studien-Informationen

Detailed Description:

Targeted anticancer therapies are often prescribed at the same dosage regimen in all patients. However, it is known that the marked interindividual variability in drug level may affect treatment outcomes. Several factors are known to modulate drug levels, such as weight, genetics host-drug and drug-drug interaction. The identification of these factors could give the possibility to propose better adjusted dosage regimens according to patient's individual characteristics. Moreover, the presence of high or low drug concentrations may partially explain toxicity or lack of efficacy of targeted anticancer drugs in some patients. The characterization of the relationship between drug levels and treatment response (efficacy and toxicity) would allow an optimized and a more individualized patient management with targeted anticancer drugs.

Oral targeted therapies must be taken on the long term and adherence issues have been shown to compromise treatment efficacy. Side effects and lifestyle management are among factors affecting treatment adherence. The characterization of adherence over time and the identification of factors susceptible to improve it will represent a great benefit for healthcare professionals and patients.
 

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Cancer patients to whom a targeted anticancer therapy is prescribed

Exclusion Criteria:

- Patients incapable of judgment or participants under tutelage

Studien-Rationale

Primary outcome:

1. Blood concentrations of targeted anticancer drugs (Time Frame - A maximum of 8 blood samples are collected within 2 years after the inclusion (at maximum 1 blood sample per month).):
During their medical visits, from 1 to 8 blood samples will be collected per patients at the same moment as routine blood sampling. Drug concentration will be measured by HPLC-MS/MS.

2. Apparition of adverse events of targeted anticancer drugs (Time Frame - Adverse events are monitored at each medical visit (once per month) from the inclusion in the study during 2 years maximum or from the inclusion in the study to the end of the treatment.):
Adverse events are assessed during the routine medical visits according the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE scale).

3. Change from treatment start in efficacy of targeted anticancer drugs (Time Frame - The cancer progression is evaluated at each PET-scan (once per 3 months) from the inclusion in the study during 2 years maximum or from the inclusion in the study to the end of the treatment.):
The progression free survival (PFS) is used to evaluate the drug efficacy. The PFS is defined as the time interval between the first dose of drug and the date of progression or any cause death. Patient without progression at the study end will be censored.

Secondary outcome:

1. Medication adherence : persistence rate and daily implementation of targeted anticancer drugs (Time Frame - 12 months):
Adherence to oral anticancer therapies will be monitored thanks to Electronic monitoring Systems (MEMS, AARDEX) during maximum 12 months. This is a 1:1 randomized medication adherence intervention, which compares an intervention group vs. usual care. The intervention consists in monthly motivational interviewing sessions between the patient and the pharmacist, along with the delivering of oral targeted anticancer drugs in electronic pill bottles (Electronic Event Monitoring EEM, MEMSTM, AARDEX Ltd.). The patient meet the pharmacist after each clinical visits (usually once per month).
 

Studien-Arme

  • No Intervention: Standard care
    Patients in the "standard care" arm will use an electronic adherence monitor (MEMS®) without any feedback (electronic data will be blinded to patients, clinicians and investigators until the analysis)
  • Experimental: Adherence program
    Patients in the "adherence program" will use the MEMS® and the pharmacist will provide an electronic feedback on medication adherence since the last visit. The identified determinants of medication adherence will be discussed with the patient.

Geprüfte Regime

  • Adherence program:
    This program combines adherence evaluation using an electronic monitor (MEMS®) and feedback with repeated medication adherence interviews with the pharmacist.

Quelle: ClinicalTrials.gov


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