NCT04045561

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
Last Updated

August 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

July 23, 2019

Last Update Submit

August 2, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • evaluating understanding

    Questionnaire. qualitative variables: measurement of their number and

    Day 1

  • 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

  • evaluating quality of information

    Questionnaire. qualitative variables: measurement of their number and percentage.

    Day 1

Secondary Outcomes (2)

  • The time required for the pharmaceutical consultation

    Day 1

  • satisfaction des patients

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • The subject is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2019

First Posted

August 5, 2019

Study Start

June 1, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

August 5, 2019

Record last verified: 2019-07