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Impact of Hospital Pharmacist on Drug Management in Patients With Bronchopulmonary Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female ≥ 18 years. 2. Patient without cognitive impairments. 3. Patient with bronchopulmonary cancer. 4. Patient treated by chemotherapy, immunotherapy or oral targeted therapy.

Exclusion Criteria:

1. Patient informed and opposed to participate. 2. Language barrier and lack of translator. 3. Patient under guardianship, curatorship or deprived of liberty. 4. Pregnant or breastfeeding women. 5. Participation in any drug clinical drug trials. 6. Patient with no insurance

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06469957
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Régional d'Orléans
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Catherine DA VIOLANTE, Dr
Principal Investigator Affiliation CHU d'Orléans
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Patients With Bronchopulmonary Cancer
Additional Details

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.

Contact a Trial Team

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International Sites

CHU d'Orléans, Orléans, France

Status

Recruiting

Address

CHU d'Orléans

Orléans, , 45067

Site Contact

Catherine DA VIOLANTE, PhD

[email protected]

+33238229962

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