Optimization of the Targeted Anticancer Therapies

NCT ID: NCT04484064

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2030-12-31

Brief Summary

The study includes an observational pharmacokinetic study and an interventional medication adherence study. The purpose of this study is 1) to describe the concentration-time profiles of targeted anticancer drugs and to characterize the concentration-effect/toxicity relationships in the target population of patients (observational study) and 2) to characterize patterns of adherence to oral targeted anticancer drugs and identify key-driver modifiable adherence factors in patients participating in an adherence program (interventional study).

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Adherence program

Intervention Type: BEHAVIORAL

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

Interventions

Adherence program

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Cancer patients to whom a targeted anticancer therapy is prescribed

Exclusion Criteria

• Patients incapable of judgment or participants under tutelage

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

OTHER

Sponsor Role: collaborator

Krebsforschung Schweiz, Bern, Switzerland

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Chantal Csajka

Director and Professor of the Center for Research and Innovation in Clinical Pharmaceutical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chantal Csajka, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacy Sciences

Locations

CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Chantal Csajka, PharmD, PhD

Role: CONTACT

chantal.csajka@chuv.ch

21 314 42 63 ext. +41

Facility Contacts

Chantal Csajka, PharmD PhD

Role: primary

chantal.csajka@chuv.ch

21 314 42 63 ext. +41

References

Bandiera C, Cardoso E, Locatelli I, Zaman K, Diciolla A, Digklia A, Stravodimou A, Cristina V, Aedo-Lopez V, Dolcan A, Sarivalasis A, Bouchaab H, Pasquier J, Dotta-Celio J, Peters S, Wagner D, Csajka C, Schneider MP. A pharmacist-led interprofessional medication adherence program improved adherence to oral anticancer therapies: The OpTAT randomized controlled trial. PLoS One. 2024 Jun 7;19(6):e0304573. doi: 10.1371/journal.pone.0304573. eCollection 2024.

Reference Type: DERIVED

PMID: 38848380 (View on PubMed)

Bandiera C, Cardoso E, Locatelli I, Digklia A, Zaman K, Diciolla A, Cristina V, Stravodimou A, Veronica AL, Dolcan A, Sarivalasis A, Liapi A, Bouchaab H, Orcurto A, Dotta-Celio J, Peters S, Decosterd L, Widmer N, Wagner D, Csajka C, Schneider MP. Optimizing Oral Targeted Anticancer Therapies Study for Patients With Solid Cancer: Protocol for a Randomized Controlled Medication Adherence Program Along With Systematic Collection and Modeling of Pharmacokinetic and Pharmacodynamic Data. JMIR Res Protoc. 2021 Jun 29;10(6):e30090. doi: 10.2196/30090.

Reference Type: DERIVED

PMID: 34185020 (View on PubMed)

Other Identifiers

65/15

Identifier Type: OTHER

Identifier Source: secondary_id

CHUV-PCL-OpTAT-2015

Identifier Type: -

Identifier Source: org_study_id