NeoplasmPHARMAIMPACT2NCT06980012
Evaluation of the Impact of the Clinical Pharmacist in Oral Therapies in Oncology.
A study testing Pharmaceutical consultation and Pharmaceutical consultation and follow-up in people with Neoplasm, run by Polyclinique Lyon Nord at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm
- What is being tested?
- Pharmaceutical consultation and Pharmaceutical consultation and follow-up
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 31 Dec 2024to 30 Sep 2027
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of the Clinical Pharmacist in the Initiation and Follow-up of 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.
- Conditions
- Neoplasm
- Being tested
- Pharmaceutical consultation, Pharmaceutical consultation and follow-up
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical consultationProcedure or surgery
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-upProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| specialized pharmaceutical consultation and follow-up in hospitals and community pharmacies | Experimental | Not described Receives: Procedure: Pharmaceutical consultation and follow-up |
| specialized pharmaceutical consultation | Active comparator | Not described Receives: Procedure: Pharmaceutical consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months and 6 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start31 Dec 2024
- Primary completion30 Jun 2026
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polyclinique Lyon Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980012
- Sponsor's protocol ID
- 2024-18-PLN
- Other IDs
- 2024-A02306-41
- Acronym
- PHARMAIMPACT2
- Status last verified
- Sep 2026
- First submitted
- 9 May 2025
- Last updated
- 5 Oct 2026
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the Clinical Pharmacist in the Initiation and Follow-up of Oral Therapies in Oncology.
- ClinicalTrials.gov ID
- NCT06980012
- Acronym / sponsor ID
- PHARMAIMPACT2 / 2024-18-PLN
- Conditions
- Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Polyclinique Lyon NordUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 May 2025 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Pharmaceutical consultationThe 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. | Procedure or surgery | specialized pharmaceutical consultation |
| Pharmaceutical consultation and follow-upAfter 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. | Procedure or surgery | specialized pharmaceutical consultation and follow-up in hospitals and community pharmacies |
Primary outcome
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.
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical consultation and Pharmaceutical consultation and follow-up in people with Neoplasm, run by Polyclinique Lyon Nord 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observance (time frame: 3 months and 6 months after treatment initiation). 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 5 Oct 2026.