Multidisciplinary Consultation ProgramIMPAMNCT04797143
Impact of a Multidisciplinary Consultation Program on Drug Adherence in First Oral Anticancer Treatment
An observational study of Multidisciplinary Consultation Program and Adherence to Oral Anticancer Treatment, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multidisciplinary Consultation Program, Adherence to Oral Anticancer Treatment, Drug Related Toxicity
- What is being tested?
- multidisciplinary consultation program
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2021to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- French speaking patients with a newly diagnosed or relapsed cancer, regardless of location and introduction of oral anticancer treatment
Who cannot join
- patients treated with hormone therapy only
- Patient with severe psychiatric disorders
- patient who does not speak the French language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Aurélie terrier-lenglet, dr, 0322087173, terrier-lenglet.aurelie@chu-amiens.fr
About this study
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.
- Conditions
- Multidisciplinary Consultation Program, Adherence to Oral Anticancer Treatment, Drug Related Toxicity, Securing Medication Management
- Being tested
- multidisciplinary consultation program
- Keywords
- Multidisciplinary consultation program, adherence to oral anticancer treatment, drug related toxicity, securing medication management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary consultation programDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| control group | patients in control group receive standard care | |
| intervention group | intervention group after implementation of a MCP Receives: Device: multidisciplinary consultation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication possession ratio (MPR)
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%.
Measured: two months
medication possession ratio (MPR)
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%.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start11 Mar 2021
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidisciplinary Consultation ProgramStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797143
- Sponsor's protocol ID
- PI2021_843_0023
- Acronym
- IMPAM
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2021
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multidisciplinary Consultation Program on Drug Adherence in First Oral Anticancer Treatment
- ClinicalTrials.gov ID
- NCT04797143
- Acronym / sponsor ID
- IMPAM / PI2021_843_0023
- Conditions
- Multidisciplinary Consultation Program, Adherence to Oral Anticancer Treatment, Drug Related Toxicity, Securing Medication Management
- Keywords
- Multidisciplinary consultation program, adherence to oral anticancer treatment, drug related toxicity, securing medication management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –patients in control group receive standard care |
| intervention group | – | Device: multidisciplinary consultation programintervention group after implementation of a MCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- French speaking patients with a newly diagnosed or relapsed cancer, regardless of location and introduction of oral anticancer treatment
Key exclusion criteria (3 listed)
- patients treated with hormone therapy only
- Patient with severe psychiatric disorders
- patient who does not speak the French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary consultation programThe 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). | Device | intervention group |
Primary outcome
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%.
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%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multidisciplinary Consultation Program and Adherence to Oral Anticancer Treatment, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélie terrier-lenglet, DR (0322087173, terrier-lenglet.aurelie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medication possession ratio (MPR) (time frame: two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.