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 (IPPACTTO)

April 21, 2022 updated by: Institut Cancerologie de l'Ouest

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

396

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49055
        • Recruiting
        • Institut de Cancérologie de l'Ouest
        • Principal Investigator:
          • Elouen BOUGHALEM, MD
        • Contact:
      • Angers, France, 49933
        • Recruiting
        • CHU
        • Contact:
        • Principal Investigator:
          • Mathilde HUNAULT Mathilde, MD
      • Cholet, France, 49300
      • La Roche-sur-Yon, France, 85925
        • Recruiting
        • CHD Vendée
        • Contact:
        • Principal Investigator:
          • Nadine MORINEAU Nadine, MD
      • Le Mans, France, 72037
      • Nantes, France, 44093
      • Saint Herblain, France, 44805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coordinated pharmaceutical path
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

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.
No Intervention: Standard of care
Patients treated with anti-cancer oral therapy who who do not benefit from an additional pharmaceutical intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the coordinated pharmaceutical path on the tolerance of oral therapies against cancer.
Time Frame: 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.
6 months from the treatment initiation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Fanny D'ACREMONT-JUTIER, OMEDIT Pays de la Loire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2019-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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