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ClinicalTrials.gov ID

NCT04327583

Lead Sponsor

Institut Cancerologie de l'OuestOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

396Estimated

Last Update Posted

Apr 28, 2022Actual

Start Date

Apr 7, 2021Actual

Primary Completion Date

Oct 2024Estimated

Completion Date

Oct 2024Estimated

Official Title

Pharmaceutical Intervention in the Coordinated Care Pathway for Cancer Patients Treated With Oral Therapy

Brief Summary

The rise of oral therapies in the management of cancers has considerably changed the patient care path. If the oral route is preferred by patients because it offers a better quality of life, it is not without impact for patients and the health professionals involved in their management in their care. Indeed, the use of the oral route shifts part of the responsibility for monitoring treatment towards the patient, thereby leading to compliance problems, drug interactions and the management of adverse effects.These risks can cause complications or compromise the effectiveness of treatment, and generate additional costs for the investigator's health system. The study proposes to involve Healthcare Facilities Pharmacist and the Dispensary Pharmacist with all other health professionals.First, the hospital pharmacist will operate before the initiation of an oral route to perform a clinical pharmaceutical analysis of drug prescriptions. Then after the primary prescription and finally during a follow-up consultation 3 months after the initiation of treatment. The hypothesis of the study is that the coordinated intervention of the hospital pharmacist and of the dispensary pharmacist would improve the tolerance of oral treatments by reducing the number of serious adverse effects found, as well as improve the, quality of life, patient and professional satisfaction

• Advanced or Metastatic Solid Tumor
• Relapsed Hematologic Malignancy

• IPPACTTO

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Patient aged 18 years old or more
• Having given his written consent to participate in the study
• Patients with advanced or metastatic solid tumor or relapsed hematologic malignancy
• With an initiation of oral therapy
• Performance Status 0, 1 or 2

Exclusion Criteria:

• Patient receiving ongoing intravenous (IV) or subcutaneous (SC) anticancer treatment
• Patient receiving ongoing oral therapy
• Patient receiving first-generation hormone therapy
• Patient receiving ongoing a coordinated pharmaceutical path
• Patient participating in a therapeutic education program including a pharmacist
• Patient already included in an interventional clinical trial
• Oral therapy with Temporary Authorisation
• Patient in a health or medico-social institution
• Patient protected, under guardianship or unable to give free and informed consent
• Patient does not speak French
• Patient unable to read French
• Patient unable to undergo the medical monitoring of the trial for geographical, social or psychological reasons.
• Patients 70 years old with cognitive disorders identified by the G-CODE

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Institut Cancerologie de l'OuestOTHER

mahunault@chu-angers.fr