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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT02849535

Collaborator

(none)

190

Enrollment

Locations

Arms

65.4

Anticipated Duration (Months)

15.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Renal Cell Carcinoma	Behavioral: PRISM care program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

190 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive 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.

Actual Study Start Date :

Oct 17, 2017

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Relative dose intensity of oral chemotherapy [6 months from the treatment initiation]
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 [6 months from the treatment initiation]
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 [6 months from the treatment initiation]
the Girerd questionnaire is a medication adherence questionnaire
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 [During the 6 months of follow-up]
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 [6 months of follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut de Cancérologie de l'Ouest	Angers	France
2	CH de Chambéry	Chambéry	France
3	Centre de Lutte Contre le Cancer Jean Perrin	Clermont-Ferrand	France
4	Centre Léon Bérard	Lyon	France
5	Hôpital Arnaud de Villeneuve	Montpellier	France
6	APHP Hôpital de la Pitié Salpétrière	Paris	France
7	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	69495
8	Institut Jean Godinot de Reims	Reims	France
9	CHU	Rouen	France
10	ICL Institut de Cancérologie de la Loire Lucien Neuwirth	Saint-Priest-en-Jarez	France
11	Hôpital Bretonneau	Tours	France
12	CH Lacari	Vichy	France