Evaluation of the Impact of the Clinical Pharmacist in Oral Therapies in Oncology.

NCT06980012 | Recruiting

• 1 other identifier: 2024-18-PLN
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The hospital pharmacist plays a vital role at the time of the patient's first prescription in a healthcare facility, to inform the patient about his or her new therapy and create a link between the hospital and the patient's home pharmacy, so that the patient can continue to receive care at home. It is also essential that the hospital pharmacy and the patient's local pharmacy work together within a reasonable timeframe. This will help improve patient care and treatment follow-up, detect any undesirable effects and optimize their management.. The aim of this prospective interventional study is to measure the benefits of pharmaceutical monitoring in healthcare institutions at the initiation of oral therapy on patient compliance, side-effect management and adherence, in comparison with patients without this monitoring. The primary endpoint is compliance with the Girerd questionnaire.

Conditions

Neoplasm

Outcome Measures

Primary Outcomes (1)

• Observance

  The measurement of the primary endpoint is based on the use of a validated scale for assessing medication compliance: the Girerd scale. This is a 6-question questionnaire with a binary yes/no response. The score ranges from 0 to 6, with a "yes" worth 1 point.

  3 months and 6 months after treatment initiation

Study Arms (2)

specialized pharmaceutical consultation and follow-up in hospitals and community pharmacies

EXPERIMENTAL

Procedure: Pharmaceutical consultation and follow-up

specialized pharmaceutical consultation

ACTIVE COMPARATOR

Procedure: Pharmaceutical consultation

Interventions

Pharmaceutical consultation PROCEDURE

The pharmaceutical interview is a structured way of carrying out an optimized medication review with the patient. This interview takes place at the time of the first prescription of oral anti-cancer treatment.

specialized pharmaceutical consultation

Pharmaceutical consultation and follow-up PROCEDURE

After the first prescription and at the treatment renewal date (+/- 2 days), the hospital pharmacist will contact the dispensing pharmacist to inform him/her of the patient's treatment, and then as part of the follow-up to detect any problems with treatment compliance (non-renewal of treatment by the patient, lack of follow-up, complaints of adverse effects by the patient). These events will be recorded in the observation book.

specialized pharmaceutical consultation and follow-up in hospitals and community pharmacies

Eligibility Criteria

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

You may qualify if:

• Patient suffering from an oncological pathology (excluding hematological malignancies)
• Initiation of a specific treatment in the context of an oncological pathology: oral therapy treatment taken at home in oncology (which may follow surgery, radiotherapy or other in-patient treatments).
• Patient who has not yet started treatment or who has started treatment less than 30 days
• Patient with continuation of oral therapy dispensed in pharmacies

You may not qualify if:

• Patients suffering from hematological malignancies
• Patient living in an institution or hospital
• Patient under treatment for more than 30 days
• Patient undergoing treatment other than oral therapy (venous or subcutaneous anticancer treatment)
• Patient whose treatment after initiation is not dispensed in a pharmacy

Sponsors & Collaborators

• Polyclinique Lyon Nord: lead

Study Sites (1)

Polyclinique Lyon Nord

Rillieux-la-Pape, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Marion Mandon, PhD

CONTACT

+33678277672; mmandon@vivalto-sante.com

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: May 9, 2025
• First Posted: May 20, 2025
• Study Start: December 31, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)