Impact of a Multidisciplinary Consultation Program on Drug Adherence in First Oral Anticancer Treatment (IMPAM)

April 1, 2025 updated by: Centre Hospitalier Universitaire, Amiens
Oncology management has changed dramatically over the last decade with the approval and rapid adoption of newly targeted oral oncology medications. The movement to oral oncology medications has altered the balance of risks and adverse effects (AEs) in the treatment of cancer care. These treatments are associated with a different constellation of AEs and drug interactions. Patients receiving treatment with oral anticancer treatment (OAT) encounter several barriers to adherence, which may include limited access to specialty medications, severe adverse effects, complex medication regimens, and special handling precautions. Medication nonadherence not only reduces the efficacy of drug therapy but also has the potential to increase healthcare expenditures due to disease-related hospitalizations. The purpose of this study is to evaluate the drug adherence in cancer patients, using the medication possession ratio (MPR), before and after the implementation of a multidisciplinary consultation program (MCP), on initiation of OAT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

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 Locations

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

Sampling Method

Non-Probability Sample

Study Population

Patients with standard treatment or after implementation of a MCP The MCP was divided into 3 steps: the first step involved a consultation with an oncologist, the second step involved a consultation with an oncology pharmacist, and the third step involved a meeting with a coordinating nurse CN. The CN put in place a regular telephone follow-up with the patient, a few days later (7 to 15 days), to ensure adherence and tolerance of the OAT.

Description

Inclusion Criteria:

  • French speaking patients with a newly diagnosed or relapsed cancer, regardless of location and introduction of oral anticancer treatment

Exclusion Criteria:

  • patients treated with hormone therapy only
  • Patient with severe psychiatric disorders
  • patient who does not speak the French language

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control group
patients in control group receive standard care
intervention group
intervention group after implementation of a MCP
Device: multidisciplinary consultation program
The multidisciplinary consultation program (MCP) was divided into 3 steps: the first step involved a consultation with an oncologist, the second step involved a consultation with an oncology pharmacist, and the third step involved a meeting with a coordinating nurse (CN). The CN put in place a regular telephone follow-up with the patient, a few days later (7 to 15 days), to ensure adherence and tolerance of the oral anticancer treatment (OAT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
medication possession ratio (MPR)
Time Frame: two months
The MPR makes it possible to determine the percentage of days of treatment covered by pharmacy dispensing. A patient is generally considered observant if MPR is greater than or equal to 80%.
two months
medication possession ratio (MPR)
Time Frame: one year
The MPR makes it possible to determine the percentage of days of treatment covered by pharmacy dispensing. A patient is generally considered observant if MPR is greater than or equal to 80%.
one year

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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)

March 11, 2021

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2021_843_0023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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