Impact of the PRISM-care Multidisciplinary Oncology Program on Secured Drug Intake of Patients With Kidney Cancer

Last updated: April 22, 2022
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urothelial Tract Cancer

Urothelial Cancer

Urologic Cancer

Treatment

N/A

Clinical Study ID

NCT02849535
69HCL14_0453
  • Ages > 18
  • All Genders

Study Summary

The rise of oral targeted therapies favors outpatient care of cancer patients but exposes them to new risks compared to the injectable chemotherapy in the hospital: non-adherence to treatment, inappropriate management of side effects and interactions with other co-prescribed drugs. The clinical consequences (reduced efficacy and potentialized toxicity) are all the more important that ambulatory monitoring of treatments prescribed at the hospital remains underdeveloped due to default of coordination between these two settings.

Adverse drug reactions are a major concern, as such, and because they involve prescription changes (dose reduction, treatment interruption). This results in a decrease in the dose taken and a risk of loss of efficacy.

In the context of metastatic renal cell carcinoma, the risk of iatrogenicity is even higher because the oral targeted therapies available in this indication have a safety profile marked by potentially serious toxicities (hematologic and cardiac toxicity) or are known to reduce the treatment adherence (digestive and skin toxicities). In addition, these molecules are metabolized by the CYP3A4 hepatic cytochrome, which leads to avoid associating them with drugs inducing and / or inhibiting the CYP3A4, because of the risk of toxicity and / or loss of efficacy.

The investigators propose to assess a program set up to secure drug taking by enhancing self-management of side effects and control of drug interactions by the patient. This program includes pharmaceutical visits and involves inpatient and outpatient (doctor, referent pharmacist and liberal nurse) professionals.

The hypothesis of the study is that the PRISM care program will improve self-management of side effects by the patient, resulting in a relative dose intensity of oral chemotherapy improved compared to usual care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient aged 18 years old or more
  • With metastatic renal cell carcinoma
  • With an initiation or change of oral targeted therapy, especially: tyrosine kinaseinhibitor (sunitinib, sorafenib, pazopanib, axitinib) or mTor inhibitor (everolimus)
  • With ambulatory status (not hospitalized for the management and treatment of itsmetastatic renal cell carcinoma)
  • Without either cognitive disorders or major psychiatric disorders
  • With a sufficient autonomy for the management of medication at home
  • Having declared an outpatient doctor
  • Having declared a usual pharmacy
  • Having given his written consent to participate in the study

Exclusion

Exclusion Criteria:

  • Significant cognitive and psychiatric disorders
  • Management of medication at home exclusively performed by the family caregiver
  • Patient in an institution or under guardianship, major protected by law
  • Patient refusing to participate in the study

Study Design

Total Participants: 190
Study Start date:
October 17, 2017
Estimated Completion Date:
April 30, 2023

Connect with a study center

  • Institut de Cancérologie de l'Ouest

    Angers,
    France

    Active - Recruiting

  • CH de Chambéry

    Chambéry,
    France

    Active - Recruiting

  • Centre de Lutte Contre le Cancer Jean Perrin

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon,
    France

    Active - Recruiting

  • Hôpital Arnaud de Villeneuve

    Montpellier,
    France

    Active - Recruiting

  • APHP Hôpital de la Pitié Salpétrière

    Paris,
    France

    Active - Recruiting

  • Hospices Civils de Lyon Groupement Hospitalier Sud Service pharmaceutique Unité de Pharmacie Clinique Oncologique Pavillon Marcel Bérard 1G 165 chemin du Grand Revoyet

    Pierre-Bénite, 69495
    France

    Active - Recruiting

  • Institut Jean Godinot de Reims

    Reims,
    France

    Active - Recruiting

  • CHU

    Rouen,
    France

    Active - Recruiting

  • ICL Institut de Cancérologie de la Loire Lucien Neuwirth

    Saint-Priest-en-Jarez,
    France

    Active - Recruiting

  • Hôpital Bretonneau

    Tours,
    France

    Active - Recruiting

  • CH Lacari

    Vichy,
    France

    Active - Recruiting

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