Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04797143
Other study ID # PI2021_843_0023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 11, 2021
Est. completion date March 2024

Study information

Verified date April 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Aurélie terrier-lenglet, DR
Phone 0322087173
Email terrier-lenglet.aurelie@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Oncology management has changed dramatically over the last decade with the approval and rapid adoption of newly targeted oral oncology medications. The movement to oral oncology medications has altered the balance of risks and adverse effects (AEs) in the treatment of cancer care. These treatments are associated with a different constellation of AEs and drug interactions. Patients receiving treatment with oral anticancer treatment (OAT) encounter several barriers to adherence, which may include limited access to specialty medications, severe adverse effects, complex medication regimens, and special handling precautions. Medication nonadherence not only reduces the efficacy of drug therapy but also has the potential to increase healthcare expenditures due to disease-related hospitalizations. The purpose of this study is to evaluate the drug adherence in cancer patients, using the medication possession ratio (MPR), before and after the implementation of a multidisciplinary consultation program (MCP), on initiation of OAT.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - French speaking patients with a newly diagnosed or relapsed cancer, regardless of location and introduction of oral anticancer treatment Exclusion Criteria: - patients treated with hormone therapy only - Patient with severe psychiatric disorders - patient who does not speak the French language

Study Design


Related Conditions & MeSH terms


Intervention

Device:
multidisciplinary consultation program
The multidisciplinary consultation program (MCP) was divided into 3 steps: the first step involved a consultation with an oncologist, the second step involved a consultation with an oncology pharmacist, and the third step involved a meeting with a coordinating nurse (CN). The CN put in place a regular telephone follow-up with the patient, a few days later (7 to 15 days), to ensure adherence and tolerance of the oral anticancer treatment (OAT).

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary medication possession ratio (MPR) The MPR makes it possible to determine the percentage of days of treatment covered by pharmacy dispensing. A patient is generally considered observant if MPR is greater than or equal to 80%. two months
Primary medication possession ratio (MPR) The MPR makes it possible to determine the percentage of days of treatment covered by pharmacy dispensing. A patient is generally considered observant if MPR is greater than or equal to 80%. one year