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

Not Applicable

Recruiting

• Conditions: Relapsed Hematologic Malignancy; Advanced or Metastatic Solid Tumor
• Interventions: Behavioral: IPPACTTO

• Registration Number: NCT04327583
• Lead Sponsor: Institut Cancerologie de l'Ouest

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-03-31
• Study Start: 2021-04-07
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coordinated pharmaceutical path	IPPACTTO	Patients treated with anti-cancer oral therapy who benefit a specific pharmaceutical follow-up by the healthcare facilities pharmacist and by the dispensary pharmacist

Primary Outcome Measures

Name	Time	Method
Impact of the coordinated pharmaceutical path on the tolerance of oral therapies against cancer.	6 months from the treatment initiation	The impact on tolerance will be measured by the proportion of patients with at least one grade 3 or 4 adverse event occurring / confirmed, linked to oral therapy, and confirmed by the oncologist.

Secondary Outcome Measures

Name	Time	Method
Impact of the coordinated pharmaceutical path on unplanned hospitalizations related to the oral therapy	6 months from the treatment initiation	Number of unplanned hospitalizations related to the oral therapy and confirmed by the oncologist.
Detection of concerted treatment modifications between oncologist and pharmacist related to oral therapy	6 months from the treatment initiation	Number of treatment modifications related to oral therapy, necessary before starting treatment and during oral therapy and confirmed by the oncologist during follow-up consultations
Impact of the coordinated pharmaceutical path on quality of life: EORTC QLQ-C30 questionnaire	Inclusion ; 1 month ; 3 months and 6 months from the treatment initiation	Quality of life for patients will be evaluated by a questionnaire before and after starting oral therapy according to the The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Impact of the coordinated pharmaceutical path on the drug related problems.	6 months from the treatment initiation	Number and nature of potential and confirmed drug related problemS detected by pharmacists
Impact of the coordinated pharmaceutical path on the number of grade 3 and 4 adverse events detected linked to oral therapy	6 months from the treatment initiation	The impact will be measured by the number of grade 3 and 4 adverse events occurring / confirmed, linked to oral therapy, and confirmed by the oncologist.
Assessment of the link between hospital and city	Through study completion, an average of 42 months	Evaluation of the link will be performed by a questionnaire to be completed by the oncologist and pharmacists. Each responds if he strongly disagrees; rather disagree; somewhat agree ; Totally agree
Impact of the coordinated pharmaceutical path on adherence to the oral therapy	1 month ; 3 months and 6 months from the treatment initiation	Adherence to the oral therapy measured with the Girerd questionnaire wich is composed of 6 questions with an expected answer yes or no. A "yes" answer is worth 1, "No" answer is worth 0. The maximum score obtained is 6; the minimum score is 0. Final Score\> 2: low compliance ; Final score = 1 or 2: average compliance ; Final score = 0: good compliance.
Satisfaction of patients related to the coordinated pharmaceutical path: questionnaire	6 months from the treatment initiation	Satisfaction of patients will be evaluated by a series of questions related to oral therapy. The patient responds if he strongly disagrees; rather disagree; somewhat agree ; Totally agree. An overall score is also required between 1 and 10; 1 is very bad; 10 is perfect

Trial Locations

Locations (6)

Institut de Cancérologie de l'Ouest; 🇫🇷 Saint Herblain, France

Chu Nantes; 🇫🇷 Nantes, France

CHU; 🇫🇷 Angers, France

Ch Le Mans; 🇫🇷 Le Mans, France

Ch Cholet; 🇫🇷 Cholet, France

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France