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

Relapsed Hematologic Malignancy Clinical Trial

— IPPACTTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04327583
• Other study ID #: ICO-2019-07
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2021
• Est. completion date: October 2024

Study information

• Verified date: April 2022
• Source: Institut Cancerologie de l'Ouest
• Contact: Fanny D'ACREMONT-JUTIER
• Phone: 02 40 84 64 47
• Email: fanny.jutier[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumor
• Hematologic Neoplasms
• Relapsed Hematologic Malignancy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
France	CHU	Angers
France	Institut de Cancérologie de l'Ouest	Angers
France	Ch Cholet	Cholet
France	CHD Vendée	La Roche-sur-Yon
France	Ch Le Mans	Le Mans
France	Chu Nantes	Nantes
France	Institut de Cancérologie de l'Ouest	Saint Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of the coordinated pharmaceutical path on the tolerance of oral therapies against cancer.	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.	6 months from the treatment initiation
Secondary	Impact of the coordinated pharmaceutical path on the number of grade 3 and 4 adverse events detected linked to oral therapy	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.	6 months from the treatment initiation
Secondary	Impact of the coordinated pharmaceutical path on unplanned hospitalizations related to the oral therapy	Number of unplanned hospitalizations related to the oral therapy and confirmed by the oncologist.	6 months from the treatment initiation
Secondary	Impact of the coordinated pharmaceutical path on the drug related problems.	Number and nature of potential and confirmed drug related problemS detected by pharmacists	6 months from the treatment initiation
Secondary	Detection of concerted treatment modifications between oncologist and pharmacist related to oral therapy	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	6 months from the treatment initiation
Secondary	Impact of the coordinated pharmaceutical path on quality of life: EORTC QLQ-C30 questionnaire	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	Inclusion ; 1 month ; 3 months and 6 months from the treatment initiation
Secondary	Impact of the coordinated pharmaceutical path on adherence to the oral therapy	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.	1 month ; 3 months and 6 months from the treatment initiation
Secondary	Satisfaction of patients related to the coordinated pharmaceutical path: questionnaire	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	6 months from the treatment initiation
Secondary	Assessment of the link between hospital and city	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	Through study completion, an average of 42 months