Impact of the PRISM-care Multidisciplinary Oncology Program on Secured Drug Intake of Patients With Kidney Cancer
PRISM care
1 other identifier
interventional
190
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2016
CompletedFirst Posted
Study publicly available on registry
July 29, 2016
CompletedStudy Start
First participant enrolled
October 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedApril 25, 2022
April 1, 2022
5.5 years
July 27, 2016
April 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months from the treatment initiation
Secondary Outcomes (19)
Adherence to the oral chemotherapy measured with the prescription renewal rate
6 months from the treatment initiation
Adherence to the oral chemotherapy measured with the Girerd questionnaire
6 months from the treatment initiation
Grade 3 and 4 adverse events related to the oral chemotherapy
6 months from the treatment initiation
Drug interactions (for patients included in the interventional group)
6 months from the treatment initiation
Cause of changes dose relative intensity: number of reduction of dosage
6 months from the treatment initiation
- +14 more secondary outcomes
Study Arms (2)
PRISM care program
EXPERIMENTALPRISM 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
NO INTERVENTIONIn 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.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
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, 69495, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine RIOUFOL, PharmD PhD
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2016
First Posted
July 29, 2016
Study Start
October 17, 2017
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
April 25, 2022
Record last verified: 2022-04