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

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ClinicalTrials.gov Identifier: NCT02849535
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 17, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Relative dose intensity of oral chemotherapy [ Time Frame: 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 :
  1. Adherence to the oral chemotherapy [ Time Frame: 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%).

  2. Grade 3 and 4 adverse events related to the oral chemotherapy [ Time Frame: 6 months from the treatment initiation ]
  3. Drug interactions (for patients included in the interventional group) [ Time Frame: 6 months from the treatment initiation ]
  4. Cause of changes dose relative intensity: number of reduction of dosage [ Time Frame: 6 months from the treatment initiation ]
  5. Cause of changes dose relative intensity: number of interruption or discontinuation of treatment [ Time Frame: 6 months from the treatment initiation ]
  6. Number of unplanned hospitalizations related to the oral chemotherapy [ Time Frame: 6 months from the treatment initiation ]
  7. Number of emergency admissions related to the oral chemotherapy [ Time Frame: 6 months from the treatment initiation ]
  8. Consumption of health care resources: number and nature of consultations with GPs and / or medical specialists [ Time Frame: 6 months from the treatment initiation ]
  9. Consumption of health care resources: number of acts of biology [ Time Frame: 6 months from the treatment initiation ]
  10. Consumption of health care resources: number of acts of imagery [ Time Frame: 6 months from the treatment initiation ]
  11. Consumption of health care resources: number of prescribed drugs and self-medication and other health products [ Time Frame: 6 months from the treatment initiation ]
  12. Quality of life, measured with the EORTC QLQ-C30 questionnaire (version 3.0) [ Time Frame: Inclusion and 6 months from the treatment initiation ]
  13. Satisfaction with treatment with medicines, measured with the SAT-MED Q questionnaire [ Time Frame: Inclusion and 6 months from the treatment initiation ]
  14. 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 ]
  15. Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale [ Time Frame: Inclusion and 6 months from the treatment initiation ]
  16. 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 ]
  17. Involvement of outpatient caregivers (doctors, pharmacists and liberal nurses) in the PRISM care program [ Time Frame: 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.

  18. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849535


Contacts
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Contact: Catherine RIOUFOL, PharmD PhD (0)4 78 86 43 70 ext +33 catherine.rioufol@chu-lyon.fr
Contact: Soumia BAYARASSOU (0)4 72 11 51 69 ext +33 soumia.bayarassou01@chu-lyon.fr

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

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02849535     History of Changes
Other Study ID Numbers: 69HCL14_0453
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Oral chemotherapy
Relative dose intensity
Health related program
Secured drug intake
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases