Impact of the Coordinated Intervention of the Healthcare Facilities Pharmacist and the Dispensary Pharmacist on the Care Pathway for Cancer Patients Treated With Oral Therapy

NCT ID: NCT04327583

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-07
• Study Completion Date: 2024-10-31

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

Conditions

Advanced or Metastatic Solid Tumor; Relapsed Hematologic Malignancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Coordinated pharmaceutical path

Patients treated with anti-cancer oral therapy who benefit a specific pharmaceutical follow-up by the healthcare facilities pharmacist and by the dispensary pharmacist

Group Type: EXPERIMENTAL

IPPACTTO

Intervention Type: BEHAVIORAL

The coordinated experimental pharmaceutical path consists of 7 pharmaceutical interviews or consultations. One initial pharmaceutical consultation with the hospital pharmacist. Five follow-up pharmaceutical interviews with the dispensary pharmacist. One follow-up pharmaceutical consultation with hospital pharmacist.

Each pharmaceutical interview or consultation will result in the drafting of a pharmaceutical report to be sent to the other participating health professionals. At each pharmaceutical consultation or interview, the pharmacists requested perform a clinical pharmaceutical analysis of drug prescriptions; Evaluate the patient's understanding; Detect adherence problems, Identify drug related problems; Alert the oncologist and / or the attending physician.

Standard of care

Patients treated with anti-cancer oral therapy who who do not benefit from an additional pharmaceutical intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IPPACTTO

The coordinated experimental pharmaceutical path consists of 7 pharmaceutical interviews or consultations. One initial pharmaceutical consultation with the hospital pharmacist. Five follow-up pharmaceutical interviews with the dispensary pharmacist. One follow-up pharmaceutical consultation with hospital pharmacist.

Each pharmaceutical interview or consultation will result in the drafting of a pharmaceutical report to be sent to the other participating health professionals. At each pharmaceutical consultation or interview, the pharmacists requested perform a clinical pharmaceutical analysis of drug prescriptions; Evaluate the patient's understanding; Detect adherence problems, Identify drug related problems; Alert the oncologist and / or the attending physician.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fanny D'ACREMONT-JUTIER

Role: PRINCIPAL_INVESTIGATOR

OMEDIT Pays de la Loire

Locations

Institut de Cancérologie de l'Ouest

Angers, , France

Site Status: RECRUITING

CHU

Angers, , France

Site Status: RECRUITING

Ch Cholet

Cholet, , France

Site Status: RECRUITING

CHD Vendée

La Roche-sur-Yon, , France

Site Status: RECRUITING

Ch Le Mans

Le Mans, , France

Site Status: RECRUITING

Chu Nantes

Nantes, , France

Site Status: RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Fanny D'ACREMONT-JUTIER

Role: CONTACT

fanny.jutier@chu-nantes.fr

02 40 84 64 47

Emilie DEBEAUPUIS

Role: CONTACT

emilie.debeaupuis@ico.unicancer.fr

Facility Contacts

Elouen BOUGHALEM, MD

Role: primary

elouen.boughalem@ico.unicancer.fr

Mathilde HUNAULT Mathilde, MD

Role: primary

mahunault@chu-angers.fr

Victor SIMMET, MD

Role: primary

victor.simmet@ch-cholet.fr

Nadine MORINEAU Nadine, MD

Role: primary

nadine.morineau@chd-vendee.fr

Oana COJOCARASU, MD

Role: primary

COJOCARASUOANA@ch-lemans.fr

Nicolas BLIN, MD

Role: primary

nicolas.blin@chu-nantes.fr

Emmanuelle BOURBOULOUX, MD

Role: primary

emmanuelle.bourbouloux@ico.unicancer.fr

Other Identifiers

ICO-2019-07

Identifier Type: -

Identifier Source: org_study_id