Clinical trial NCT02849535: Impact of the PRISM-care Multidisciplinary Oncology Program on Secured Drug Intake of Patients With Kidney Cancer
Official title: Impact of the PRISM-care Multidisciplinary Oncology Program Versus Usual Care on Secured Drug Intake of Patients With Kidney Cancer, Through Self-management of Adverse Events Related to Oral Targeted Therapies, Control of Drug Interactions, and Sharing of the Information Between Ambulatory and Hospital Settings.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Oral chemotherapy
Relative dose intensity
Health related program
Secured drug intake
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Relative dose intensity of oral chemotherapy
timeFrame: 6 months from the treatment initiation
Secondary outcomes:
measure: Adherence to the oral chemotherapy measured with the prescription renewal rate
timeFrame: 6 months from the treatment initiation
measure: Adherence to the oral chemotherapy measured with the Girerd questionnaire
timeFrame: 6 months from the treatment initiation
measure: Grade 3 and 4 adverse events related to the oral chemotherapy
timeFrame: 6 months from the treatment initiation
measure: Drug interactions (for patients included in the interventional group)
timeFrame: 6 months from the treatment initiation
measure: Cause of changes dose relative intensity: number of reduction of dosage
timeFrame: 6 months from the treatment initiation
measure: Cause of changes dose relative intensity: number of interruption or discontinuation of treatment
timeFrame: 6 months from the treatment initiation
measure: Number of unplanned hospitalizations related to the oral chemotherapy
timeFrame: 6 months from the treatment initiation
measure: Number of emergency admissions related to the oral chemotherapy
timeFrame: 6 months from the treatment initiation
measure: Consumption of health care resources: number and nature of consultations with GPs and / or medical specialists
timeFrame: 6 months from the treatment initiation
measure: Consumption of health care resources: number of acts of biology
timeFrame: 6 months from the treatment initiation
measure: Consumption of health care resources: number of acts of imagery
timeFrame: 6 months from the treatment initiation
measure: Consumption of health care resources: number of prescribed drugs and self-medication and other health products
timeFrame: 6 months from the treatment initiation
measure: Quality of life, measured with the EORTC QLQ-C30 questionnaire (version 3.0)
timeFrame: Inclusion and 6 months from the treatment initiation
measure: Satisfaction with treatment with medicines, measured with the SAT-MED Q questionnaire
timeFrame: Inclusion and 6 months from the treatment initiation
measure: Rate of patients presenting satisfying knowledge about adverse effects of their oral chemotherapy, according to the hospital pharmacists and measured with a 4-items Likert scale
timeFrame: 2 months and 6 months from the treatment initiation
measure: Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale
timeFrame: Inclusion and 6 months from the treatment initiation
measure: Patient's perception of its illness, measured with the Brief Illness Perception Questionnaire (B-IPQ)
timeFrame: Inclusion and 6 months from the treatment initiation
measure: Involvement of outpatient caregivers (doctors, pharmacists and liberal nurses) in the PRISM care program
timeFrame: During the 6 months of follow-up
measure: Satisfaction of outpatient caregivers (doctors, pharmacists and liberal nurses) relative to the PRISM care program, measured with a rating out of 10
timeFrame: 6 months of follow-up
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: Chambéry
country: France
facility: CH de Chambéry
city: Clermont-Ferrand
country: France
facility: Centre de Lutte Contre le Cancer Jean Perrin
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Paris
country: France
facility: APHP Hôpital de la Pitié Salpétrière
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon Groupement Hospitalier Sud Service pharmaceutique Unité de Pharmacie Clinique Oncologique Pavillon Marcel Bérard 1G 165 chemin du Grand Revoyet
city: Reims
country: France
facility: Institut Jean Godinot de Reims
city: Rouen
country: France
facility: CHU
city: Saint-Priest-en-Jarez
country: France
facility: ICL Institut de Cancérologie de la Loire Lucien Neuwirth
city: Tours
country: France
facility: Hôpital Bretonneau
city: Vichy
country: France
facility: CH Lacari
Study officials:
affiliation: Hospices Civils de Lyon
name: Catherine RIOUFOL, PharmD PhD
role: PRINCIPAL_INVESTIGATOR
References: