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

Primary Purpose

Metastatic Renal Cell Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PRISM care program
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Renal Cell Carcinoma focused on measuring Oral chemotherapy, Relative dose intensity, Health related program, Secured drug intake

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut de Cancérologie de l'OuestRecruiting
  • CH de ChambéryRecruiting
  • Centre de Lutte Contre le Cancer Jean PerrinRecruiting
  • Centre Léon BérardRecruiting
  • Hôpital Arnaud de VilleneuveRecruiting
  • APHP Hôpital de la Pitié SalpétrièreRecruiting
  • Hospices Civils de Lyon Groupement Hospitalier Sud Service pharmaceutique Unité de Pharmacie Clinique Oncologique Pavillon Marcel Bérard 1G 165 chemin du Grand RevoyetRecruiting
  • Institut Jean Godinot de ReimsRecruiting
  • CHURecruiting
  • ICL Institut de Cancérologie de la Loire Lucien NeuwirthRecruiting
  • Hôpital BretonneauRecruiting
  • CH LacariRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PRISM care program

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adherence to the oral chemotherapy measured with the prescription renewal rate
Adherence will be measured with the prescription renewal rate by the ambulatory pharmacy (adherence will be defined as a rate ≥80%).
Adherence to the oral chemotherapy measured with the Girerd questionnaire
the Girerd questionnaire is a medication adherence questionnaire
Grade 3 and 4 adverse events related to the oral chemotherapy
Drug interactions (for patients included in the interventional group)
Cause of changes dose relative intensity: number of reduction of dosage
Cause of changes dose relative intensity: number of interruption or discontinuation of treatment
Number of unplanned hospitalizations related to the oral chemotherapy
Number of emergency admissions related to the oral chemotherapy
Consumption of health care resources: number and nature of consultations with GPs and / or medical specialists
Consumption of health care resources: number of acts of biology
Consumption of health care resources: number of acts of imagery
Consumption of health care resources: number of prescribed drugs and self-medication and other health products
Quality of life, measured with the EORTC QLQ-C30 questionnaire (version 3.0)
Satisfaction with treatment with medicines, measured with the SAT-MED Q questionnaire
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
Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale
Patient's perception of its illness, measured with the Brief Illness Perception Questionnaire (B-IPQ)
Involvement of outpatient caregivers (doctors, pharmacists and liberal nurses) in the PRISM care program
Involvement will be described by the number and type of: interventions recorded on a dedicated form, solicitations of hospital staff, treatment modifications realized in concertation between oncologist and outpatient doctor.
Satisfaction of outpatient caregivers (doctors, pharmacists and liberal nurses) relative to the PRISM care program, measured with a rating out of 10

Full Information

First Posted
July 27, 2016
Last Updated
April 22, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02849535
Brief Title
Impact of the PRISM-care Multidisciplinary Oncology Program on Secured Drug Intake of Patients With Kidney Cancer
Acronym
PRISM care
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma
Keywords
Oral chemotherapy, Relative dose intensity, Health related program, Secured drug intake

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRISM care program
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PRISM care program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relative dose intensity of oral chemotherapy
Description
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.
Time Frame
6 months from the treatment initiation
Secondary Outcome Measure Information:
Title
Adherence to the oral chemotherapy measured with the prescription renewal rate
Description
Adherence will be measured with the prescription renewal rate by the ambulatory pharmacy (adherence will be defined as a rate ≥80%).
Time Frame
6 months from the treatment initiation
Title
Adherence to the oral chemotherapy measured with the Girerd questionnaire
Description
the Girerd questionnaire is a medication adherence questionnaire
Time Frame
6 months from the treatment initiation
Title
Grade 3 and 4 adverse events related to the oral chemotherapy
Time Frame
6 months from the treatment initiation
Title
Drug interactions (for patients included in the interventional group)
Time Frame
6 months from the treatment initiation
Title
Cause of changes dose relative intensity: number of reduction of dosage
Time Frame
6 months from the treatment initiation
Title
Cause of changes dose relative intensity: number of interruption or discontinuation of treatment
Time Frame
6 months from the treatment initiation
Title
Number of unplanned hospitalizations related to the oral chemotherapy
Time Frame
6 months from the treatment initiation
Title
Number of emergency admissions related to the oral chemotherapy
Time Frame
6 months from the treatment initiation
Title
Consumption of health care resources: number and nature of consultations with GPs and / or medical specialists
Time Frame
6 months from the treatment initiation
Title
Consumption of health care resources: number of acts of biology
Time Frame
6 months from the treatment initiation
Title
Consumption of health care resources: number of acts of imagery
Time Frame
6 months from the treatment initiation
Title
Consumption of health care resources: number of prescribed drugs and self-medication and other health products
Time Frame
6 months from the treatment initiation
Title
Quality of life, measured with the EORTC QLQ-C30 questionnaire (version 3.0)
Time Frame
Inclusion and 6 months from the treatment initiation
Title
Satisfaction with treatment with medicines, measured with the SAT-MED Q questionnaire
Time Frame
Inclusion and 6 months from the treatment initiation
Title
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
Time Frame
2 months and 6 months from the treatment initiation
Title
Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale
Time Frame
Inclusion and 6 months from the treatment initiation
Title
Patient's perception of its illness, measured with the Brief Illness Perception Questionnaire (B-IPQ)
Time Frame
Inclusion and 6 months from the treatment initiation
Title
Involvement of outpatient caregivers (doctors, pharmacists and liberal nurses) in the PRISM care program
Description
Involvement will be described by the number and type of: interventions recorded on a dedicated form, solicitations of hospital staff, treatment modifications realized in concertation between oncologist and outpatient doctor.
Time Frame
During the 6 months of follow-up
Title
Satisfaction of outpatient caregivers (doctors, pharmacists and liberal nurses) relative to the PRISM care program, measured with a rating out of 10
Time Frame
6 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine RIOUFOL, PharmD PhD
Phone
(0)4 78 86 43 70
Ext
+33
Email
catherine.rioufol@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Soumia BAYARASSOU
Phone
(0)4 72 11 51 69
Ext
+33
Email
soumia.bayarassou01@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine RIOUFOL, PharmD PhD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Remy DELVA
Facility Name
CH de Chambéry
City
Chambéry
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mélanie TADJ LESAGE
Facility Name
Centre de Lutte Contre le Cancer Jean Perrin
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hakim MAHAMMEDI
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen BOYLE
Facility Name
Hôpital Arnaud de Villeneuve
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clothilde LINDET -BOURGEOIS
Facility Name
APHP Hôpital de la Pitié Salpétrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haide BOOSTAN
Facility Name
Hospices Civils de Lyon Groupement Hospitalier Sud Service pharmaceutique Unité de Pharmacie Clinique Oncologique Pavillon Marcel Bérard 1G 165 chemin du Grand Revoyet
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine RIOUFOL, PharmD
Phone
(0)4 78 86 43 70
Ext
+33
Email
catherine.rioufol@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Soumia BAYARASSOU
Phone
(0)4 72 11 51 69
Ext
+33
Email
soumia.bayarassou01@chu-lyon.fr
Facility Name
Institut Jean Godinot de Reims
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe EYMARD
Facility Name
CHU
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fréderic DI FIORE
Facility Name
ICL Institut de Cancérologie de la Loire Lucien Neuwirth
City
Saint-Priest-en-Jarez
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline GUILLOT
Facility Name
Hôpital Bretonneau
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claude LINASSIER
Facility Name
CH Lacari
City
Vichy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souad SALHI

12. IPD Sharing Statement

Learn more about this trial

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

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