Impact of the PRISM-care Multidisciplinary Oncology Program on Secured Drug Intake of Patients With Kidney Cancer
NCT ID: NCT02849535
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
190 participants
INTERVENTIONAL
2017-10-17
2023-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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PRISM care program
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.
PRISM care program
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.
Standard of care
In the group with standard of care, patients will have interviews with a hospital pharmacist only dedicated to the record of data for outcomes assessment. These sessions will be planned at the beginning of month 1, month 2 and month 3 after the inclusion , and at the end at month 6 after the final physical session.
No interventions assigned to this group
Interventions
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PRISM care program
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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Catherine RIOUFOL, PharmD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Institut de Cancérologie de l'Ouest
Angers, , France
CH de Chambéry
Chambéry, , France
Centre de Lutte Contre le Cancer Jean Perrin
Clermont-Ferrand, , France
Centre Léon Bérard
Lyon, , France
Hôpital Arnaud de Villeneuve
Montpellier, , France
APHP Hôpital de la Pitié Salpétrière
Paris, , France
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
Institut Jean Godinot de Reims
Reims, , France
CHU
Rouen, , France
ICL Institut de Cancérologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Hôpital Bretonneau
Tours, , France
CH Lacari
Vichy, , France
Countries
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Central Contacts
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Facility Contacts
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Remy DELVA
Role: primary
Mélanie TADJ LESAGE
Role: primary
Hakim MAHAMMEDI
Role: primary
Helen BOYLE
Role: primary
Clothilde LINDET -BOURGEOIS
Role: primary
Haide BOOSTAN
Role: primary
Jean-Christophe EYMARD
Role: primary
Fréderic DI FIORE
Role: primary
Aline GUILLOT
Role: primary
Claude LINASSIER
Role: primary
Souad SALHI
Role: primary
Other Identifiers
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69HCL14_0453
Identifier Type: -
Identifier Source: org_study_id
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