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

September 7, 2023 updated by: Centre Hospitalier Universitaire de Nīmes

An Evaluation Study on the Performance of a Guided Clinical Pharmacy Consultation for Patients With Multiple Myeloma Following Their First Oral Anticancer Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Dijon University Hospital Pharmacy
      • Perpignan, France, 66000
        • Perpignan Hospital Center
    • Occitanie
      • Nîmes, Occitanie, France, 30029
        • Nimes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Guided Clinical Pharmacy Consultation
These patients will have the benefit of a Guided Clinical Pharmacy Consultation
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observance of treatment by patients following Revlimid - Velcade - Dexamethasone protocol who had the benefit of a Guided Clinical Pharmacy Consultation
Time Frame: End of treatment. Day 21 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
End of treatment. Day 21 +/- 5 days
Observance of treatment by patients following Revlimid - Dexamethazone protocol who had the benefit of the Guided Clinical Pharmacy Consultation
Time Frame: End of treatment. Day 28 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
End of treatment. Day 28 +/- 5 days
Observance of treatment by patients following Revlimid - Velcade - Dexamethasone protocol who did not not have the benefit of a Guided Clinical Pharmacy Consultation
Time Frame: End of treatment. Day 21 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
End of treatment. Day 21 +/- 5 days
Observance of treatment by patients following Revlimid - Dexamethazone protocol who did not have the benefit of the Guided Clinical Pharmacy Consultation
Time Frame: End of treatment. Day 28 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage
End of treatment. Day 28 +/- 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results of the self-questionnaire for patients following the Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 21 +/- 5 days
Percentage of right answers to the self-questionnaire testing patient's knowledge and understanding of treatment as explained in the guide given at the time of the consultation for patients benefitting from the guided clinical pharmacy consultation
End of treatment. Day 21 +/- 5 days
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
Time Frame: End of treatment. Day 21 +/- 5 days
Percentage of right answers to the self-questionnaire testing patient's knowledge and understanding of treatment.
End of treatment. Day 21 +/- 5 days
Results of the self-questionnaire for patients following the Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation
Time Frame: End of treatment. Day 28 +/- 5 days
Percentage of right answers to the self-questionnaire testing patient's knowledge and understanding of treatment as explained in the guide given at the time of the consultation for patients benefitting from the guided clinical pharmacy consultation
End of treatment. Day 28 +/- 5 days
Results of the self-questionnaire for patients following the Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation
Time Frame: End of treatment. Day 28 +/- 5 days
Percentage of right answers to the self-questionnaire testing patient's knowledge and understanding of treatment.
End of treatment. Day 28 +/- 5 days
System Usability Score for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 21 +/- 5 days
The System Usability Score is a set of 10 questions with a 5-point Lickert scale ranging from "I disagree" to "I completely agree". The satisfaction score ranges from 0 to 100.
End of treatment. Day 21 +/- 5 days
System Usability Score for patients following Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 21 +/- 5 days
The System Usability Score is a set of 10 questions with a 5-point Lickert scale ranging from "I disagree" to "I completely agree". The satisfaction score ranges from 0 to 100.
End of treatment. Day 21 +/- 5 days
System Usability Score for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 28 +/- 5 days
The System Usability Score is a set of 10 questions with a 5-point Lickert scale ranging from "I disagree" to "I completely agree". The satisfaction score ranges from 0 to 100.
End of treatment. Day 28 +/- 5 days
System Usability Score for patients following Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 28 +/- 5 days
The System Usability Score is a set of 10 questions with a 5-point Lickert scale ranging from "I disagree" to "I completely agree". The satisfaction score ranges from 0 to 100.
End of treatment. Day 28 +/- 5 days
Semi-directive interview for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 21 +/- 5 days

The following events are that may have affected treatment observance are noted:

fever over 38.5°, Nosebleeds or bleeding gums, Breathlessness, respiratory difficulties, Chest pain, Swelling, pain or redness in the legs, Digestive difficulties, Insomnia, Fatigue, Tingling, Numb fingers or toes
End of treatment. Day 21 +/- 5 days
Semi-directive interview for patients following Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 21 +/- 5 days

The following events are that may have affected treatment observance are noted:

fever over 38.5°, Nosebleeds or bleeding gums, Breathlessness, respiratory difficulties, Chest pain, Swelling, pain or redness in the legs, Digestive difficulties, Insomnia, Fatigue, Tingling, Numb fingers or toes
End of treatment. Day 21 +/- 5 days
Semi-directive interview for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 28 +/- 5 days

The following events are that may have affected treatment observance are noted:

fever over 38.5°, Nosebleeds or bleeding gums, Breathlessness, respiratory difficulties, Chest pain, Swelling, pain or redness in the legs, Digestive difficulties, Insomnia, Fatigue, Tingling, Numb fingers or toes
End of treatment. Day 28 +/- 5 days
Semi-directive interview for patients following Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 28 +/- 5 days

The following events are that may have affected treatment observance are noted:

fever over 38.5°, Nosebleeds or bleeding gums, Breathlessness, respiratory difficulties, Chest pain, Swelling, pain or redness in the legs, Digestive difficulties, Insomnia, Fatigue, Tingling, Numb fingers or toes
End of treatment. Day 28 +/- 5 days
Pill-count for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 21 +/- 5 days
Treatment observance rate as a percentage deduced from the number of pills prescribed and the number of pills taken.
End of treatment. Day 21 +/- 5 days
Pill-count for patients following Revlimid - Velcade - Dexamethasone protocol who did not benefit from the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 21 +/- 5 days
Treatment observance rate as a percentage deduced from the number of pills prescribed and the number of pills taken.
End of treatment. Day 21 +/- 5 days
Pill-count for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 28 +/- 5 days
Treatment observance rate as a percentage deduced from the number of pills prescribed and the number of pills taken.
End of treatment. Day 28 +/- 5 days
Pill-count for patients following Revlimid - Dexamethazone protocol who did not benefit from the guided clinical pharmacy consultation.
Time Frame: End of treatment. Day 28 +/- 5 days
Treatment observance rate as a percentage deduced from the number of pills prescribed and the number of pills taken.
End of treatment. Day 28 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Velcade - Dexamethasone protocol who benefitted from the Guided Clinical Pharmacy Consultation
Time Frame: End of treatment. Day 21 +/- 5 days
The following items recorded on the patient's journal - treatment begun in due time, right molecule taken at the right time, respect for days without medication, day when treatment was stopped - will be converted into a percentage rate of discrepancies.
End of treatment. Day 21 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Velcade - Dexamethasone protocol who did not benefit from the Guided Clinical Pharmacy Consultation
Time Frame: End of treatment. Day 21 +/- 5 days
The following items recorded on the patient's journal - treatment begun in due time, right molecule taken at the right time, respect for days without medication, day when treatment was stopped - will be converted into a percentage rate of discrepancies.
End of treatment. Day 21 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Dexamethazone protocol who benefitted from the Guided Clinical Pharmacy Consultation
Time Frame: End of treatment. Day 28 +/- 5 days
The following items recorded on the patient's journal - treatment begun in due time, right molecule taken at the right time, respect for days without medication, day when treatment was stopped - will be converted into a percentage rate of discrepancies.
End of treatment. Day 28 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Dexamethazone protocol who did not benefit from the Guided Clinical Pharmacy Consultation
Time Frame: End of treatment. Day 28 +/- 5 days
The following items recorded on the patient's journal - treatment begun in due time, right molecule taken at the right time, respect for days without medication, day when treatment was stopped - will be converted into a percentage rate of discrepancies.
End of treatment. Day 28 +/- 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Collaborators

Centre Hospitalier Universitaire Dijon
Perpignan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIMAO/2018-01/MF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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