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

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

Study Overview

• Status: Completed
• Conditions: Chemotherapy Effect; G-CHOP Chemotherapy; R-CHOP Chemotherapy
• Intervention / Treatment: Other: Assessment of patient satisfaction regarding tele-consultation; Other: Literacy questionnaire; Other: Collection of socio-demographic characteristics; Other: Assessment of patient knowledge on chemotherapy side effects and support medications; Other: Assessment of patient satisfaction on pharmaceutical follow-up

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

• Study Contact: Name: Catherine RIOUFOL, Pr.; Phone Number: +33478864368; Email: catherine.rioufol@chu-lyon.fr
• Study Contact Backup: Name: amandine baudouin, Dr; Phone Number: +33478864368; Email: amandine.baudouin@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite, France, 69495
    • Hôpital Lyon Sud - Hospices Civils de Lyon
    • Contact: catherine Rioufol, PhD, PharmaD; Phone Number: +33478864368; Email: catherine.rioufol@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

150 patients treated in the hematology department of a university hospital

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

R-CHOP or G-CHOP chemotherapy; Patients with hematological malignancies receiving R-CHOP or G-CHOP chemotherapy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Haematology; Pharmaceutical Care
• Other Study ID Numbers: 69HCL22_0292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No