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

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.

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 Overview

• Status: Recruiting
• Conditions: Metastatic Renal Cell Carcinoma
• Intervention / Treatment: Behavioral: PRISM care program

• Study Type: Interventional
• Enrollment (Anticipated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine RIOUFOL, PharmD PhD; Phone Number: +33 (0)4 78 86 43 70; Email: catherine.rioufol@chu-lyon.fr
• Study Contact Backup: Name: Soumia BAYARASSOU; Phone Number: +33 (0)4 72 11 51 69; Email: soumia.bayarassou01@chu-lyon.fr

Study Locations

• France
  • Angers, France
    • Recruiting
    • Institut de Cancérologie de l'Ouest
    • Contact: Remy DELVA
  • Chambéry, France
    • Recruiting
    • Ch De Chambery
    • Contact: Mélanie TADJ LESAGE
  • Clermont-Ferrand, France
    • Recruiting
    • Centre de Lutte Contre le Cancer Jean PERRIN
    • Contact: Hakim MAHAMMEDI
  • Lyon, France
    • Recruiting
    • Centre Leon Berard
    • Contact: Helen BOYLE
  • Montpellier, France
    • Recruiting
    • Hopital Arnaud de Villeneuve
    • Contact: Clothilde LINDET -BOURGEOIS
  • Paris, France
    • Recruiting
    • APHP Hôpital de la Pitié Salpètrière
    • Contact: Haide BOOSTAN
  • Pierre-Bénite, France, 69495
    • Recruiting
    • Hospices Civils de Lyon Groupement Hospitalier Sud Service pharmaceutique Unité de Pharmacie Clinique Oncologique Pavillon Marcel Bérard 1G 165 chemin du Grand Revoyet
    • Contact: Soumia BAYARASSOU; Phone Number: +33 (0)4 72 11 51 69; Email: soumia.bayarassou01@chu-lyon.fr
    • Contact: Catherine RIOUFOL, PharmD; Phone Number: +33 (0)4 78 86 43 70; Email: catherine.rioufol@chu-lyon.fr
  • Reims, France
    • Recruiting
    • Institut Jean Godinot de Reims
    • Contact: Jean-Christophe EYMARD
  • Rouen, France
    • Recruiting
    • CHU
  • Saint-Priest-en-Jarez, France
    • Recruiting
    • ICL Institut de Cancérologie de la Loire Lucien Neuwirth
    • Contact: Aline GUILLOT
  • Tours, France
    • Recruiting
    • Hopital Bretonneau
    • Contact: Claude LINASSIER
  • Vichy, France
    • Recruiting
    • CH Lacari
    • Contact: Souad SALHI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: 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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%).	6 months from the treatment initiation
Adherence to the oral chemotherapy measured with the Girerd questionnaire	the Girerd questionnaire is a medication adherence 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
Cause of changes dose relative intensity: number of interruption or discontinuation of treatment		6 months from the treatment initiation
Number of unplanned hospitalizations related to the oral chemotherapy		6 months from the treatment initiation
Number of emergency admissions related to the oral chemotherapy		6 months from the treatment initiation
Consumption of health care resources: number and nature of consultations with GPs and / or medical specialists		6 months from the treatment initiation
Consumption of health care resources: number of acts of biology		6 months from the treatment initiation
Consumption of health care resources: number of acts of imagery		6 months from the treatment initiation
Consumption of health care resources: number of prescribed drugs and self-medication and other health products		6 months from the treatment initiation
Quality of life, measured with the EORTC QLQ-C30 questionnaire (version 3.0)		Inclusion and 6 months from the treatment initiation
Satisfaction with treatment with medicines, measured with the SAT-MED Q questionnaire		Inclusion and 6 months from the treatment initiation
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		2 months and 6 months from the treatment initiation
Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale		Inclusion and 6 months from the treatment initiation
Patient's perception of its illness, measured with the Brief Illness Perception Questionnaire (B-IPQ)		Inclusion and 6 months from the treatment initiation
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.	During the 6 months of follow-up
Satisfaction of outpatient caregivers (doctors, pharmacists and liberal nurses) relative to the PRISM care program, measured with a rating out of 10		6 months of follow-up

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Catherine RIOUFOL, PharmD PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2017
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (ESTIMATE): July 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Oral chemotherapy; Relative dose intensity; Health related program; Secured drug intake
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: 69HCL14_0453

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No