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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04045561
Other study ID # LOCAL/2015/MF-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2015
Est. completion date December 31, 2016

Study information

Verified date July 2019
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type Measure Description Time frame Safety issue
Primary evaluating the understanding Questionnaire. quantitative variables: measurement of the mean and standard deviation or by their median and quartiles according to their distribution. Day 1
Primary evaluating understanding Questionnaire. qualitative variables: measurement of their number and Day 1
Primary evaluating the quality of information Questionnaire. quantitative variables: measurement of the mean and standard deviation or by their median and quartiles according to their distribution. Day 1
Primary evaluating quality of information Questionnaire. qualitative variables: measurement of their number and percentage. Day 1
Secondary The time required for the pharmaceutical consultation minutes Day 1
Secondary satisfaction des patients by an Analogue Visual Scale (0-10-very satisfied) Day 1
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