Multidisciplinary Care Program to Secure MEdication Therapy for HematoLOgy Patients Receiving Injectable Anticancer Drugs

NCT05350930 | Completed

• 1 other identifier: 69HCL22_0292
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chemotherapy Effect; G-CHOP Chemotherapy; R-CHOP Chemotherapy

Keywords

Haematology; Pharmaceutical Care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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; 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

Interventions

Assessment of patient satisfaction regarding tele-consultation OTHER

Questionnaire completed following the teleconsultation, if applicable.

R-CHOP or G-CHOP chemotherapy

Literacy questionnaire OTHER

Questionnaire completed during hospitalization for the first chemotherapy cycle

R-CHOP or G-CHOP chemotherapy

Collection of socio-demographic characteristics OTHER

Questionnaire completed during patient hospitalization for the first chemotherapy cycle

R-CHOP or G-CHOP chemotherapy

Assessment of patient knowledge on chemotherapy side effects and support medications OTHER

Questionnaire completed during patient hospitalization for the first, second and sixth cycle of chemotherapy

R-CHOP or G-CHOP chemotherapy

Assessment of patient satisfaction on pharmaceutical follow-up OTHER

Questionnaire completed during patient hospitalization for the sixth chemotherapy cycle

R-CHOP or G-CHOP chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 patients treated in the hematology department of a university hospital

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Lyon Sud - Hospices Civils de lyon

Pierre-Bénite, 69495, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: June 9, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

FR (1)