Evaluation Study on Performance of Guided Clinical Pharmacy Consultation in Patients With Multiple Myeloma on First Oral Anticancer Treatment

NCT ID: NCT04309942

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2023-05-30

Brief Summary

Nowadays, more and more patients are receiving anticancer treatment by mouth and oral chemotherapy is a challenge for our health system as patients become autonomous and responsible for following their oral anti-cancer treatment at home.

According to the French National Cancer Institute around 5.000 new cases of multiple myeloma (MM) are detected each year, and this figure is on the increase. It is more common in people aged over 70. The patterns of oral anticancer medication for multiple myeloma are complex and these patients do not always follow their treatment correctly. A clinical pharmaceutical consultation guide was designed to overcome this problem.Our hypothesis is that the guided consultation would minimize the rate of discrepancies observed compared with the usual, standard type of management.

The main objective is therefore to evaluate the performance of this guided consultation (interventional group) in comparison with a control group (standard management) for patients with multiple myeloma on their first cure of oral anticancer medication.

Detailed Description

Nowadays, more and more patients are receiving anticancer treatment by mouth. In this context, the development of oral chemotherapy represents a challenge to our health system as it means adapting the hospital's organization and making it safer to manage patients who are becoming autonomous and responsible for following their oral anti-cancer treatment at home.

According to the French National Cancer Institute, around 5,000 new cases of multiple myeloma (MM) are detected each year, and this figure is on the increase year by year. It is more common in people aged over 70. Patients treated have several risk factors for not respecting medication adherence such as age, polypharmacy related to the presence of other chronic pathologies, and associated comorbidities. Furthermore, the patterns of administering oral anticancer medication for multiple myeloma are complex.

In a previous study we designed a clinical pharmaceutical consultation guide with a view to improving patients' adherence to their oral anticancer treatment. This guide was designed and validated by a multidisciplinary workgroup to ensure that it was readable, understandable and easy to memorize for the patients being treated for multiple myeloma. The guide was designed so that the information given was reproducible from one patient to another, whoever the pharmacist might be, by standardizing the information given. Our hypothesis is that the guided consultation would make it possible to minimize the rate of discordance observed compared with the usual, standard type of management.

The main objective of this study is to evaluate the performance of the guided consultation (Intervention) by evaluating the rate of discrepancies observed compared with the theoretical therapeutic pattern prescribed, compared with a control group(standard management) for patients with multiple myeloma on their first cure of oral anticancer medication.

Secondary objectives are:

A. For both groups in the study, evaluate the patients' level of knowledge and understanding of their treatment.

B. In the interventional group, evaluate the acceptability of the intervention by the patient.

C. For both groups in the study, evaluate the attitude of the patients when faced with intercurrent events (foreseeable with oral anticancer treatment) for example : fever over 38.5°C, nosebleeds and /or bleeding gums, breathlessness, respiratory difficulties, chest pain, swelling, pain or redness in the legs, digestive difficulties, insomnia, fatigue, tingling, numb fingers or toes.

D. For both groups in the study, evaluate the adherence to treatment (adherence rate in percentages).

E. Evaluate the rate of discrepancies per item : treatment started in due time, right molecule taken at the right moment, respect of days when no medication is to be taken, day when treatment is to be stopped.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Guided Clinical Pharmacy Consultation group

Patients following either Revlimid - Velcade - Dexamethasone or Revlimid - Dexamethasone protocols with the benefit of a Guided Clinical Pharmacy Consultation before beginning oral anticancer treatment for multiple myeloma.

Group Type: EXPERIMENTAL

Guided Clinical Pharmacy Consultation

Intervention Type: OTHER

These patients will have the benefit of a Guided Clinical Pharmacy Consultation

Standard group

Patients following either Revlimid - Velcade - Dexamethazone or Revlimid - Dexamethazone protocols but without the benefit of a Guided Clinical Pharmacy Consultation before beginning oral anticancer treatment for multiple myeloma.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Guided Clinical Pharmacy Consultation

These patients will have the benefit of a Guided Clinical Pharmacy Consultation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All patients being treated for multiple myeloma receiving their first oral anticancer treatment.
• All patients being treated for multiple myeloma by autologous peripheral stem cell graft following the Revlimid - Velcade - Dexamethazone protocol
• All patients who cannot be treated for multiple myeloma by autologous peripheral stem cell graft and who are following the Revlimid - Dexamethazone protocol
• All patients who have given written informed consent.
• All patients who have signed the consent form.
• All patients covered by a health insurance scheme

Exclusion Criteria

• All patients requiring help at home from a nurse for taking their oral treatment
• All patients participating in another category 1 research project.
• All patients in an exclusion period determined by another study.
• All patients for whom it is impossible to give enlightened information.
• All patients who are pregnant or breastfeeding

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de Perpignan

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nîmes University Hospital

Nîmes, Occitanie, France

Dijon University Hospital Pharmacy

Dijon, , France

Perpignan Hospital Center

Perpignan, , France

Countries

France

Other Identifiers

NIMAO/2018-01/MF

Identifier Type: -

Identifier Source: org_study_id