CHOPIN: Role of the Pharmacist in Detection of Drug Interactions Before Antitumor Treatment Initiation

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04142567
Collaborator
(none)
440
1
22.7
19.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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.)

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    440 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Role of the Clinical Pharmacist in an Oncology Ambulatory Center to Prevent Drug Related Problems Before Antitumor Treatment Initiation
    Actual Study Start Date :
    Feb 11, 2020
    Actual Primary Completion Date :
    Apr 23, 2021
    Anticipated Study Completion Date :
    Jan 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of Pharmacist intervention [up to 1 week from date of inclusion]

      Percentage of patients whom antitumora treatment or usual treatment has been changed by the pharmacist intervention

    Secondary Outcome Measures

    1. Detection of Drug -drug interactions [up to 1 week from date of inclusion]

      Number of drug drug interactions detected

    2. Clinical gradation of drug drug interactions [One year]

      Gradation by an independent experts comity of the clinical impact of prevented drug drug interaction

    3. Cost of the pharmacist intervention by avoided clinical consequence [One year]

      Cost evaluation of pharmacist for analysis and medication review with patient by avoided interaction

    4. Potential cost of the avoided clinical consequences [One year]

      Treatment cost of avoided clinical consequences , balanced with the probability of occurrence

    5. Adherence evaluation with oral cancer targeted therapy by therapeutic drug monitoring [day 15, 30 and 6 months after oral therapy initiation]

      Patients with plasma drug concentration below the 10th percentile will be classified as nonadherent patients

    6. Adherence evaluation with oral cancer targeted therapy by the 6 item-Girerd Scale [day 15, 30 and 6 months after oral therapy initiation]

      Patients with a Girerd score greater than or equal to 3 will be classified as nonadherent patients

    7. Adherence evaluation with oral cancer targeted therapy by pill count [6 months after oral therapy initiation]

      Pill counts will be used to calculate the percent of total prescribed dose taken to prescribed during the 90-day period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 APHP -Cochin Hospital and Georges Pompidou European Hospital Paris France 75014

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Audrey Thomas-Schoemann, PharmD, PhD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT04142567
    Other Study ID Numbers:
    • 2018-A03512-53
    First Posted:
    Oct 29, 2019
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris

    Study Results

    No Results Posted as of Dec 21, 2021