Multidisciplinary Care Program to Secure mEdication Therapy for hematoLOgy Patients Receiving Injectable Anticancer Drugs

Chemotherapy Effect Clinical Trial

— Melodia  

Official title:

Multidisciplinary Care Program to Secure mEdication Therapy for hematoLOgy Patients Receiving Injectable Anticancer Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05350930
• Other study ID #: 69HCL22_0292
• Status: Completed
• Start date: June 9, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: December 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Several experiences of multidisciplinary care pathways associating oncologists, pharmacists and nurses have been reported for cancer patients, with positive results on medication management safety, reduction of Drug-Related Problems (DRPs), and re-hospitalizations. This study aims to evaluate the impact of a multidisciplinary city-hospital follow-up program on medication management safety in haematological oncology patients receiving intravenous chemotherapy in onco-haematology. Additional aspects will be evaluated, such as the impact of the follow-up on the city-hospital link, satisfaction of patients and professionals involved in the follow-up and the use of telecare

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult patients aged 18 years or older With hematological malignancy at any stage Initiating R-CHOP or G-CHOP chemotherapy Who do not object to participation in the study and use of collected data

Exclusion Criteria:

• Patients already enrolled in a clinical trial evaluating any drug product
• Patients living in an institution
• Patients protected by law
• Adults subject to a legal protection measure (curatorship, guardianship) (article L1121-8 of the CSP)
• Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and persons admitted to a health or social establishment (article L1121-6 of the CSP)

Related Conditions & MeSH terms

• Chemotherapy Effect

Intervention

Other:
• Assessment of patient satisfaction regarding tele-consultation
Questionnaire completed following the teleconsultation, if applicable.
• Literacy questionnaire
Questionnaire completed during hospitalization for the first chemotherapy cycle
• Collection of socio-demographic characteristics
Questionnaire completed during patient hospitalization for the first chemotherapy cycle
• Assessment of patient knowledge on chemotherapy side effects and support medications
Questionnaire completed during patient hospitalization for the first, second and sixth cycle of chemotherapy
• Assessment of patient satisfaction on pharmaceutical follow-up
Questionnaire completed during patient hospitalization for the sixth chemotherapy cycle

Locations

Country	Name	City	State
France	Hôpital Lyon Sud - Hospices Civils de lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the clinical impact of pharmacist interventions at first cycle of chemotherapy, according to the CLEO© scale.	Each pharmacist intervention performed during patient follow-up will be rated according to its expected level of clinic impact (major, moderate, minor, null)	6 months after inclusion