Clinical trial NCT04327583: 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
Official title: Pharmaceutical Intervention in the Coordinated Care Pathway for Cancer Patients Treated With Oral Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced or Metastatic Solid Tumor
Relapsed Hematologic Malignancy
Keywords: Anti cancer oral therapy
Pharmaceutical intervention
Adverse events
Drug interactions
Coordinated care pathway
Drug related problem
Adherence
Quality of life
Pharmaceutical care
Clinical pharmacy
Oncology pharmacy
Hospital pharmacist
Patient satisfaction
Patient care team
Community pharmacist
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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 outcomes:
measure: Impact of the coordinated pharmaceutical path on the tolerance of oral therapies against cancer.
timeFrame: 6 months from the treatment initiation
Secondary outcomes:
measure: Impact of the coordinated pharmaceutical path on the number of grade 3 and 4 adverse events detected linked to oral therapy
timeFrame: 6 months from the treatment initiation
measure: Impact of the coordinated pharmaceutical path on unplanned hospitalizations related to the oral therapy
timeFrame: 6 months from the treatment initiation
measure: Impact of the coordinated pharmaceutical path on the drug related problems.
timeFrame: 6 months from the treatment initiation
measure: Detection of concerted treatment modifications between oncologist and pharmacist related to oral therapy
timeFrame: 6 months from the treatment initiation
measure: Impact of the coordinated pharmaceutical path on quality of life: EORTC QLQ-C30 questionnaire
timeFrame: Inclusion ; 1 month ; 3 months and 6 months from the treatment initiation
measure: Impact of the coordinated pharmaceutical path on adherence to the oral therapy
timeFrame: 1 month ; 3 months and 6 months from the treatment initiation
measure: Satisfaction of patients related to the coordinated pharmaceutical path: questionnaire
timeFrame: 6 months from the treatment initiation
measure: Assessment of the link between hospital and city
timeFrame: Through study completion, an average of 42 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: Angers
country: France
facility: CHU
city: Cholet
country: France
facility: Ch Cholet
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Mans
country: France
facility: Ch Le Mans
city: Nantes
country: France
facility: Chu Nantes
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
Study officials:
affiliation: OMEDIT Pays de la Loire
name: Fanny D'ACREMONT-JUTIER
role: PRINCIPAL_INVESTIGATOR
References: