Development of a Standardized Reference Guide for Tuning Adherence to Dispense During a Initial Pharmaceutical Consulting (CP ) to the Patient With Multiple Myeloma Oral Chemotherapy Primocure

August 2, 2019 updated by: Centre Hospitalier Universitaire de Nīmes

Elaboration of a Standardized Referential Guide of the Information to Optimize the Adherence to be Given During an Initial Pharmaceutical Consultation (CP) to the Patient Suffering From Multiple Myeloma in Primocure Chemotherapy Per os

The hypothesis is that the implementation of an initial Pharmaceutical Consultation (PC) program based on the provision of standardized information to patients treated for multiple myeloma as a first course of chemotherapy, could optimize their compliance with the delivered per os treatment.

The aim of this study is therefore to develop a standardised reference guide of information to be provided during prostate cancer in order to optimise the compliance of patients treated for multiple myeloma as a first course of chemotherapy per os.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patient is treated for multiple myeloma, is naive to any treatment and begins a chemotherapy protocol with oral therapy and whose course of care includes a stay in the Day Hospital or retrocessions.

Description

Inclusion criteria

  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is at least 18 years old
  • The patient is treated for multiple myeloma, is naive to any treatment and begins a chemotherapy protocol with oral therapy and whose course of care includes a stay in the Day Hospital or retrocessions.

Criteria for non-inclusion

  • The subject is participating in another study
  • The subject is in an exclusion period determined by a previous study
  • The subject is under the protection of justice, guardianship or curatorship
  • It is impossible to give informed information about
  • The patient is pregnant, parturient, or breastfeeding
  • The patient receives a follow-up by a home nurse for the administration of oral medication
  • The patient is treated only with oral chemotherapy in the city
  • The patient has early dementia.

Translated with www.DeepL.com/Translator

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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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluating the understanding
Time Frame: Day 1
Questionnaire. quantitative variables: measurement of the mean and standard deviation or by their median and quartiles according to their distribution.
Day 1
evaluating understanding
Time Frame: Day 1
Questionnaire. qualitative variables: measurement of their number and
Day 1
evaluating the quality of information
Time Frame: Day 1
Questionnaire. quantitative variables: measurement of the mean and standard deviation or by their median and quartiles according to their distribution.
Day 1
evaluating quality of information
Time Frame: Day 1
Questionnaire. qualitative variables: measurement of their number and percentage.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time required for the pharmaceutical consultation
Time Frame: Day 1
minutes
Day 1
satisfaction des patients
Time Frame: Day 1
by an Analogue Visual Scale (0-10-very satisfied)
Day 1

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

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)

June 1, 2015

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL/2015/MF-01

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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