Clinical trial NCT06469957: Impact of Hospital Pharmacist on Drug Management in Patients With Bronchopulmonary Cancer
Official title: Impact of Hospital Pharmacist on Drug Management in Patients With Bronchopulmonary Cancer Treated by Chemotherapy and/or Immunotherapy or Oral Targeted Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients With Bronchopulmonary Cancer
Keywords: Hospital pharmacist
Pharmaceutical intervention
Chemotherapy / Immunotherapy /oral targeted therapy
Bronchopulmonary cancer
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bronchopulmonary cancer who received a new treatment with oral targeted therapy, chemotherapy or immunotherapy.

Brief 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. 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.

Eligibility 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

Primary outcomes:
measure: Impact of hospital pharmacist (interview) on the number of unscheduled consultations/hospitalizations.
timeFrame: From enrolment to the end of the follow up phase (6 months)
Secondary outcomes:
measure: Impact of hospital pharmacist (interview) on cancelled consultations/hospitalizations rate
timeFrame: From enrolment to the end of the follow up phase (6 months)
measure: Impact of hospital pharmacist (interview) on treatment observance (number of dispensation)
timeFrame: From enrolment to the end of the follow up phase (6 months)
measure: Impact of hospital pharmacist (interview) on treatment observance (gap between dispensation)
timeFrame: From enrolment to the end of the follow up phase (6 months)
measure: Impact of hospital pharmacist (interview) on adverse effects
timeFrame: From enrolment to the end of the follow up phase (6 months)
measure: Impact of hospital pharmacist (interview) on adverse effects leading to interrupted or withdrawn treatment
timeFrame: From enrolment to the end of the follow up phase (6 months)
measure: Impact of hospital pharmacist on pharmaceutical intervention
timeFrame: From enrolment to the end of the follow up phase (6 months)
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHU d'Orléans
Study officials:
affiliation: CHU d'Orléans
name: Catherine DA VIOLANTE, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.