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NCT Number: NCT06980012

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinique Lyon Nord

Rillieux-la-Pape, France

Location status: Recruiting

Location contact

Marion Mandon, PhD

CONTACT

[email protected]

+33678277672

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Observance

    Time frame: 3 months and 6 months after treatment initiation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marion Mandon, PhD

CONTACT

[email protected]

+33678277672

Sponsors and collaborators

Lead sponsor

Polyclinique Lyon Nord

Other

Registry information

Official study title

Evaluation of the Impact of the Clinical Pharmacist in the Initiation and Follow-up of Oral Therapies in Oncology.

Acronym: Pharmaimpact

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 20, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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