- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06469957
Impact of Hospital Pharmacist on Drug Management in Patients With Bronchopulmonary Cancer (IMPACTO)
Impact of Hospital Pharmacist on Drug Management in Patients With Bronchopulmonary Cancer Treated by Chemotherapy and/or Immunotherapy or Oral Targeted Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Orléans, France, 45067
- CHU d'Orléans
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female ≥ 18 years
- Patient without cognitive impairments
- Patient with bronchopulmonary cancer
- Patient treated by chemotherapy, immunotherapy or oral targeted therapy
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From enrolment to the end of the follow up phase (6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of hospital pharmacist (interview) on cancelled consultations/hospitalizations rate
Time Frame: From enrolment to the end of the follow up phase (6 months)
|
Number of cancelled consultations/hospitalizations
|
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)
|
Number of adverse effects (follow up phase of 6 months)
|
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)
|
Number of adverse effects leading to interrupted or withdrawn treatment
|
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)
|
Number of pharmaceutical interventions (eg.
inappropriate prescription, drug interactions)
|
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)
|
Number of treatment dispensation
|
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)
|
Gap between each treatment dispensation
|
From enrolment to the end of the follow up phase (6 months)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Catherine DA VIOLANTE, Dr, CHU d'Orléans
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRO-2023-12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Patients With Bronchopulmonary Cancer
-
Centre Francois BaclesseCompletedPatients With CancerFrance
-
Philogen S.p.A.TerminatedPatients With CancerItaly, United Kingdom
-
JING MINGXUENational University of SingaporeNot yet recruiting
-
Second Affiliated Hospital, School of Medicine,...Sir Run Run Shaw Hospital; Zhejiang Provincial People's HospitalActive, not recruitingCancer Patients With PICCChina
-
Sichuan Cancer Hospital and Research InstituteEnrolling by invitationGeriatric Assessment | Geriatric Patients | Assessment Tool | Patients With CancerChina
-
Greater Baltimore Medical CenterWithdrawnCancer | Patients With Clinical and Environmental Risk Factors for Cancer | Patients With a Suspected or Confirmed Diagnosis of CancerUnited States
-
Hospices Civils de LyonUnknown
-
Persei VivariumEffice Servicios Para la Investigacion S.L.CompletedCancer Patients With Outpatient TreatmentSpain
-
Elevar TherapeuticsBukwang Pharmaceutical, Co., Ltd.CompletedCancer Patients With Solid TumorsKorea, Republic of, United States
-
China Medical University HospitalChina Medical University, TaiwanActive, not recruitingCancer Patients With Solid Tumors | Cancer (Advanced Stage)Taiwan
Clinical Trials on Questionnaires and data collection sheet
-
Assistance Publique - Hôpitaux de ParisRecruitingIntensive Care Unit Syndrome | Pediatric Post-intensive Care SyndromeFrance
-
Centre Hospitalier Universitaire DijonCompletedNon-hodgkin's LymphomaFrance
-
University Hospital, Basel, SwitzerlandActive, not recruitingSkin CancerSwitzerland
-
Centre Hospitalier Universitaire DijonNot yet recruitingFollicular Lymphoma | Diffuse Large Cell Diffuse LymphomaFrance
-
University GhentRecruitingPediatric ObesityBelgium
-
Assistance Publique - Hôpitaux de ParisLFB BIOMEDICAMENTSRecruitingQuality of Life | Small Fiber Neuropathy | Primary Sjögren Syndrome | Medico-economic ImpactFrance
-
M.D. Anderson Cancer CenterCompletedAdvanced CancersUnited States
-
Centre Hospitalier Universitaire DijonCompletedAntenatal Congenital MalformationsFrance
-
Fondation LenvalRecruitingInflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)France