Patients With Bronchopulmonary CancerIMPACTONCT06469957
Impact of Hospital Pharmacist on Drug Management in Patients With Bronchopulmonary Cancer
An observational study of Patients With Bronchopulmonary Cancer, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
This is a prospective, non-interventional study to evaluate impact of hospital pharmacist on drug management in patients (only questionnaires) with bronchopulmonary cancer treated by Chemotherapy and/or Immunotherapy or Oral targeted therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Bronchopulmonary Cancer
- What is being tested?
- Questionnaires and data collection sheet
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 bronchopulmonary cancer who received a new treatment with oral targeted therapy, chemotherapy or immunotherapy.
Who may be able to join
- Male or female ≥ 18 years
- Patient without cognitive impairments
- Patient with bronchopulmonary cancer
- Patient treated by chemotherapy, immunotherapy or oral targeted therapy
Who cannot join
- Patient informed and opposed to participate
- Language barrier and lack of translator
- Patient under guardianship, curatorship or deprived of liberty
- Pregnant or breastfeeding women
- Participation in any drug clinical drug trials
- Patient with no insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Hospital Pharmacist on Drug Management in Patients With Bronchopulmonary Cancer Treated by Chemotherapy and/or Immunotherapy or Oral Targeted Therapy
This is a prospective, non-interventional study to evaluate impact of hospital pharmacist on drug management in patients (only questionnaires) with bronchopulmonary cancer treated by Chemotherapy and/or Immunotherapy or Oral targeted therapy. The primary objective of the study is to evaluate the number of unscheduled consultations/hospitalizations during 6 months.
Read the detailed description
Currently, several treatments can be used for bronchopulmonary cancers: targeted oral therapy (OCT), oral chemotherapy, iv chemotherapy, iv immunotherapy. These therapies are rather unknown to community pharmacy and induce several adverse effects and drug interactions. These treatments require collaboration between different professionals (community and hospital pharmacists) in order to allow follow up and security in patient supportive care.
In our context of shortage of care staff, with a polymedicated and elderly population, we would like to assess the impact of hospital pharmacist in the drug management for patient with bronchopulmonary cancers treated by these therapies.
Other French studies (Lille, Angers, Tours) involving hospital pharmacists were carried out and aimed to evaluate the number of pharmaceutical interventions carried out without assessing the impact on the patient. In addition, no study concerns the Center Val de Loire region.
The aim of the study is to impact of hospital pharmacist (interview) on the number of unscheduled consultations/hospitalizations.
This is a prospective, non-interventional study to evaluate impact of hospital pharmacist on drug management in patients with bronchopulmonary cancer. Participants will be included after being informed and after obtaining no opposition to participate. Data collection sheet will be performed by hospital pharmacist at inclusion. Participants will be treated according to standard of care for cancer treatment. An interview will be performed 1 month, 3 months and 6 months after inclusion between hospital pharmacist and participant to obtain information's on cancer treatments (questionnaires). These interviews will be performed by phone or when the patient comes to the hospital for a follow-up consultation as part of the treatment of his cancer (standard of care).
A total of 60 participants will be included in this study based on 1) the number of patients received a novel cancer treatment in the center during 12 months and 2) considered eligibility criteria, pharmacist availability and patients consent.
- Conditions
- Patients With Bronchopulmonary Cancer
- Being tested
- Questionnaires and data collection sheet
- Keywords
- Hospital pharmacist, Pharmaceutical intervention, Chemotherapy / Immunotherapy /oral targeted therapy, Bronchopulmonary cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and data collection sheetOther
Questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of hospital pharmacist (interview) on the number of unscheduled consultations/hospitalizations.
Number of unscheduled consultations or hospitalizations during the follow up phase
Measured: From enrolment to the end of the follow up phase (6 months)
Secondary outcomes (6)
Impact of hospital pharmacist (interview) on cancelled consultations/hospitalizations rate
Number of cancelled consultations/hospitalizations
Measured: From enrolment to the end of the follow up phase (6 months)
Impact of hospital pharmacist (interview) on treatment observance (number of dispensation)
Number of treatment dispensation
Measured: From enrolment to the end of the follow up phase (6 months)
Impact of hospital pharmacist (interview) on treatment observance (gap between dispensation)
Gap between each treatment dispensation
Measured: From enrolment to the end of the follow up phase (6 months)
Impact of hospital pharmacist (interview) on adverse effects
Number of adverse effects (follow up phase of 6 months)
Measured: From enrolment to the end of the follow up phase (6 months)
Impact of hospital pharmacist (interview) on adverse effects leading to interrupted or withdrawn treatment
Number of adverse effects leading to interrupted or withdrawn treatment
Measured: From enrolment to the end of the follow up phase (6 months)
Impact of hospital pharmacist on pharmaceutical intervention
Number of pharmaceutical interventions (eg. inappropriate prescription, drug interactions)
Measured: From enrolment to the end of the follow up phase (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start25 Jun 2024
- Primary completion23 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Bronchopulmonary CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine DA VIOLANTE, Dr, Principal investigator, CHU d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469957
- Sponsor's protocol ID
- CHRO-2023-12
- Acronym
- IMPACTO
- Status last verified
- Mar 2026
- First submitted
- 3 Jun 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Babin M, Folliard C, Robert J, Sorrieul J, Kieffer H, Augereau P, Devys C. [Pharmaceutical consultations in oncology: Implementation, one-year review and outlooks]. Ann Pharm Fr. 2019 Sep;77(5):426-434. doi: 10.1016/j.pharma.2019.05.001. Epub 2019 Jul 7. French.
PubMed 31288930
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hospital Pharmacist on Drug Management in Patients With Bronchopulmonary Cancer Treated by Chemotherapy and/or Immunotherapy or Oral Targeted Therapy
- ClinicalTrials.gov ID
- NCT06469957
- Acronym / sponsor ID
- IMPACTO / CHRO-2023-12
- Conditions
- Patients With Bronchopulmonary Cancer
- Keywords
- Hospital pharmacist, Pharmaceutical intervention, Chemotherapy / Immunotherapy /oral targeted therapy, Bronchopulmonary cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Jun 2024 (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.
This is a prospective, non-interventional study to evaluate impact of hospital pharmacist on drug management in patients (only questionnaires) with bronchopulmonary cancer treated by Chemotherapy and/or Immunotherapy or Oral targeted therapy. The primary objective of the study is to evaluate the number of unscheduled consultations/hospitalizations during 6 months.
Detailed description
Currently, several treatments can be used for bronchopulmonary cancers: targeted oral therapy (OCT), oral chemotherapy, iv chemotherapy, iv immunotherapy. These therapies are rather unknown to community pharmacy and induce several adverse effects and drug interactions. These treatments require collaboration between different professionals (community and hospital pharmacists) in order to allow follow up and security in patient supportive care.
In our context of shortage of care staff, with a polymedicated and elderly population, we would like to assess the impact of hospital pharmacist in the drug management for patient with bronchopulmonary cancers treated by these therapies.
Other French studies (Lille, Angers, Tours) involving hospital pharmacists were carried out and aimed to evaluate the number of pharmaceutical interventions carried out without assessing the impact on the patient. In addition, no study concerns the Center Val de Loire region.
The aim of the study is to impact of hospital pharmacist (interview) on the number of unscheduled consultations/hospitalizations.
This is a prospective, non-interventional study to evaluate impact of hospital pharmacist on drug management in patients with bronchopulmonary cancer. Participants will be included after being informed and after obtaining no opposition to participate. Data collection sheet will be performed by hospital pharmacist at inclusion. Participants will be treated according to standard of care for cancer treatment. An interview will be performed 1 month, 3 months and 6 months after inclusion between hospital pharmacist and participant to obtain information's on cancer treatments (questionnaires). These interviews will be performed by phone or when the patient comes to the hospital for a follow-up consultation as part of the treatment of his cancer (standard of care).
A total of 60 participants will be included in this study based on 1) the number of patients received a novel cancer treatment in the center during 12 months and 2) considered eligibility criteria, pharmacist availability and patients consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bronchopulmonary cancer who received a new treatment with oral targeted therapy, chemotherapy or immunotherapy.
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years
- Patient without cognitive impairments
- Patient with bronchopulmonary cancer
- Patient treated by chemotherapy, immunotherapy or oral targeted therapy
Key exclusion criteria (6 listed)
- Patient informed and opposed to participate
- Language barrier and lack of translator
- Patient under guardianship, curatorship or deprived of liberty
- Pregnant or breastfeeding women
- Participation in any drug clinical drug trials
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 |
|---|---|---|
| Questionnaires and data collection sheetQuestionnaires | Other | – |
Primary outcome
Impact of hospital pharmacist (interview) on the number of unscheduled consultations/hospitalizations.
Time frame: From enrolment to the end of the follow up phase (6 months)
Number of unscheduled consultations or hospitalizations during the follow up phase
6 secondary outcomes
Impact of hospital pharmacist (interview) on cancelled consultations/hospitalizations rate
Time frame: From enrolment to the end of the follow up phase (6 months)
Impact of hospital pharmacist (interview) on treatment observance (number of dispensation)
Time frame: From enrolment to the end of the follow up phase (6 months)
Impact of hospital pharmacist (interview) on treatment observance (gap between dispensation)
Time frame: From enrolment to the end of the follow up phase (6 months)
Impact of hospital pharmacist (interview) on adverse effects
Time frame: From enrolment to the end of the follow up phase (6 months)
Impact of hospital pharmacist (interview) on adverse effects leading to interrupted or withdrawn treatment
Time frame: From enrolment to the end of the follow up phase (6 months)
Impact of hospital pharmacist on pharmaceutical intervention
Time frame: From enrolment to the end of the follow up phase (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 31288930Babin M, Folliard C, Robert J, Sorrieul J, Kieffer H, Augereau P, Devys C. [Pharmaceutical consultations in oncology: Implementation, one-year review and outlooks]. Ann Pharm Fr. 2019 Sep;77(5):426-434. doi: 10.1016/j.pharma.2019.05.001. Epub 2019 Jul 7. French.
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Influence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV
Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French Recommendations
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.
Catherine DA VIOLANTE, Dr principal investigator
CHU d'Orléans
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 Patients With Bronchopulmonary Cancer, run by Centre Hospitalier Régional d'Orléans 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 6 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: finished, as of the sponsor's last update on 20 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Impact of hospital pharmacist (interview) on the number of unscheduled consultations/hospitalizations. (time frame: From enrolment to the end of the follow up phase (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06469957, which also lists 1 linked publication.
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 20 Mar 2026.