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

Hospices Civils de Lyon190 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Interventions

PRISM care programBEHAVIORAL

PRISM care is a multidisciplinary program that includes sessions with a hospital pharmacist about the oral chemotherapy: information is given to the patient on adverse events occurrence and management, optimizing drug dosage plan, including drug-drug interactions. Physical sessions will be planned at the beginning of month 1, month 2 and month 3 after the inclusion, then telephone interviews of physical sessions will be planned at month 4, month 5 and month 6. During all these sessions and during the final physical session at the end of month 6, data will be recorded for outcomes assessment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 kinase inhibitor (sunitinib, sorafenib, pazopanib, axitinib) or mTor inhibitor (everolimus) * With ambulatory status (not hospitalized for the management and treatment of its metastatic 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 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

Locations (12)

Institut de Cancérologie de l'Ouest

Angers, France

RECRUITING

CH de Chambéry

Chambéry, France

RECRUITING

Centre de Lutte Contre le Cancer Jean Perrin

Clermont-Ferrand, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Hôpital Arnaud de Villeneuve

Montpellier, France

RECRUITING

APHP Hôpital de la Pitié Salpétrière

Paris, France

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, France

RECRUITING

Institut Jean Godinot de Reims

Reims, France

RECRUITING

CHU

Rouen, France

RECRUITING

ICL Institut de Cancérologie de la Loire Lucien Neuwirth

Saint-Priest-en-Jarez, France

RECRUITING

...and 2 more locations

Outcomes

Primary Outcomes

Relative dose intensity of oral chemotherapy

Relative dose intensity will be computed by the ratio between the overall dose delivered and the overall dose prescribed during the 6 months of follow-up.