Clinical trial NCT04309942: Evaluation Study on Performance of Guided Clinical Pharmacy Consultation in Patients With Multiple Myeloma on First Oral Anticancer Treatment
Official title: An Evaluation Study on the Performance of a Guided Clinical Pharmacy Consultation for Patients With Multiple Myeloma Following Their First Oral Anticancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Oral anticancer treatment
Observance
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Centre hospitalier de Perpignan
name: Centre Hospitalier Universitaire Dijon
First posted: 2020-03-17
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric, prospective, randomized controlled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Observance of treatment by patients following Revlimid - Velcade - Dexamethasone protocol who had the benefit of a Guided Clinical Pharmacy Consultation
timeFrame: End of treatment. Day 21 +/- 5 days
measure: Observance of treatment by patients following Revlimid - Dexamethazone protocol who had the benefit of the Guided Clinical Pharmacy Consultation
timeFrame: End of treatment. Day 28 +/- 5 days
measure: Observance of treatment by patients following Revlimid - Velcade - Dexamethasone protocol who did not not have the benefit of a Guided Clinical Pharmacy Consultation
timeFrame: End of treatment. Day 21 +/- 5 days
measure: Observance of treatment by patients following Revlimid - Dexamethazone protocol who did not have the benefit of the Guided Clinical Pharmacy Consultation
timeFrame: End of treatment. Day 28 +/- 5 days
Secondary outcomes:
measure: Results of the self-questionnaire for patients following the Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 21 +/- 5 days
measure: Results of the self-questionnaire for patients following the Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation
timeFrame: End of treatment. Day 21 +/- 5 days
measure: Results of the self-questionnaire for patients following the Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation
timeFrame: End of treatment. Day 28 +/- 5 days
measure: Results of the self-questionnaire for patients following the Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation
timeFrame: End of treatment. Day 28 +/- 5 days
measure: System Usability Score for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 21 +/- 5 days
measure: System Usability Score for patients following Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 21 +/- 5 days
measure: System Usability Score for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 28 +/- 5 days
measure: System Usability Score for patients following Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 28 +/- 5 days
measure: Semi-directive interview for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 21 +/- 5 days
measure: Semi-directive interview for patients following Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 21 +/- 5 days
measure: Semi-directive interview for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 28 +/- 5 days
measure: Semi-directive interview for patients following Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 28 +/- 5 days
measure: Pill-count for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 21 +/- 5 days
measure: Pill-count for patients following Revlimid - Velcade - Dexamethasone protocol who did not benefit from the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 21 +/- 5 days
measure: Pill-count for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 28 +/- 5 days
measure: Pill-count for patients following Revlimid - Dexamethazone protocol who did not benefit from the guided clinical pharmacy consultation.
timeFrame: End of treatment. Day 28 +/- 5 days
measure: Rate of discrepancies per item in patients on Revlimid - Velcade - Dexamethasone protocol who benefitted from the Guided Clinical Pharmacy Consultation
timeFrame: End of treatment. Day 21 +/- 5 days
measure: Rate of discrepancies per item in patients on Revlimid - Velcade - Dexamethasone protocol who did not benefit from the Guided Clinical Pharmacy Consultation
timeFrame: End of treatment. Day 21 +/- 5 days
measure: Rate of discrepancies per item in patients on Revlimid - Dexamethazone protocol who benefitted from the Guided Clinical Pharmacy Consultation
timeFrame: End of treatment. Day 28 +/- 5 days
measure: Rate of discrepancies per item in patients on Revlimid - Dexamethazone protocol who did not benefit from the Guided Clinical Pharmacy Consultation
timeFrame: End of treatment. Day 28 +/- 5 days
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nîmes University Hospital
state: Occitanie
city: Dijon
country: France
facility: Dijon University Hospital Pharmacy
city: Perpignan
country: France
facility: Perpignan Hospital Center
Study officials:
References: