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

NCT04327583 | Unknown

• 1 other identifier: ICO-2019-07
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 7

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• Impact of the coordinated pharmaceutical path on unplanned hospitalizations related to the oral therapy

  6 months from the treatment initiation

• Impact of the coordinated pharmaceutical path on the drug related problems.

  6 months from the treatment initiation

• Detection of concerted treatment modifications between oncologist and pharmacist related to oral therapy

  6 months from the treatment initiation

• 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

Study Arms (2)

Coordinated pharmaceutical path

EXPERIMENTAL

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

Behavioral: IPPACTTO

Standard of care

NO INTERVENTION

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

Interventions

IPPACTTO 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.

Coordinated pharmaceutical path

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (7)

Institut de Cancérologie de l'Ouest

Angers, 49055, France

RECRUITING

CHU

Angers, 49933, France

RECRUITING

Ch Cholet

Cholet, 49300, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, 85925, France

RECRUITING

Ch Le Mans

Le Mans, 72037, France

RECRUITING

Chu Nantes

Nantes, 44093, France

RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Hematologic Neoplasms; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Fanny D'ACREMONT-JUTIER

  OMEDIT Pays de la Loire

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fanny D'ACREMONT-JUTIER

CONTACT

02 40 84 64 47; fanny.jutier@chu-nantes.fr

Emilie DEBEAUPUIS

CONTACT

emilie.debeaupuis@ico.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 31, 2020
• Study Start: April 7, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

FR (7)