- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03806712
Comprehensive Study of Social Representation of Platelet Transfusion in Patients Followed for Advanced Hematological Malignancies (R-PLQ) (R-PLQ)
July 24, 2019 updated by: Centre Hospitalier Universitaire de Besançon
Limited data is available for end of life care in hematologic malignancies, moreover with thrombocytopenic patients.
Thrombopenia is a frequent complication, specific of bone marrow involvement in those diseases or its treatments.
Yet, a few studies was interested in, whereas platelet transfusion is the only treatment indicated.
As it represent a scarce, limited resource, the ethical principles are in conflict in this setting and there's a lack of recommendation.
The final decision is take by the clinician and his patient, but no study exist in representation of the two parts.
We provide a qualitative study to understand what this decision is made of.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
45
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
-
-
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Besançon, France, 25000
- Moracchini
-
-
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 to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient with advanced hematological malignancies, transfused in platelet regulary, hematologist's nurses who practice platelet transfusion and hematologist who prescribe the transfusion.
Description
Inclusion Criteria:
- major patient
- patient with advanced hematological malignancies
- patient transfused in platelet regularly (3 time at least in last month)
- medical practioner, hematologist, prescribing platelet transfusion at least one per week.
- nurse working in hematology, practicing platelet transfusion at lest one peer week.
Exclusion Criteria:
- minor patient
- non communicant patient
- non transfused platelet patient
- non voluntary patient or hematologist or nurses
- non graduated hematologist
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patient
patient with advanced, non curative hematological malignancies multi method questionary, at least 1 hour per patient
|
questions from an association network according to the subject and the grounded theorise (Glasser and Strauss)
|
|
hematologist
medical practitioner of platelet transfusion multi method questionary, at least 1 hour per hematologist
|
questions from an association network according to the subject and the grounded theorise (Glasser and Strauss)
|
|
Nurses
nurses working in hematology, practicing platelet transfusion multi method questionary, at least 1 hour per nurse
|
questions from an association network according to the subject and the grounded theorise (Glasser and Strauss)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measure the impact of social representation on platelet transfusion practice
Time Frame: 3 months
|
inner core and peripheral items of platelet transfusion of each participant will be collected until reaching saturation, it's to say that the repetition of some terms will be measured between each interview thank's to a questionnaire of at least two principals opened questions.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McGrath P, Leahy M. Catastrophic bleeds during end-of-life care in haematology: controversies from Australian research. Support Care Cancer. 2009 May;17(5):527-37. doi: 10.1007/s00520-008-0506-1. Epub 2008 Sep 23.
- McGrath P, Holewa H. Special considerations for haematology patients in relation to end-of-life care: Australian findings. Eur J Cancer Care (Engl). 2007 Mar;16(2):164-71. doi: 10.1111/j.1365-2354.2006.00745.x.
- Jeoffrion C, Dupont P, Tripodi D, Roland-Levy C. [Social representations of illness: Comparison of "expert" knowledge and "naive" knowledge]. Encephale. 2016 Jun;42(3):226-33. doi: 10.1016/j.encep.2015.12.007. Epub 2016 Jan 12. French.
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)
April 1, 2019
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
July 22, 2019
Study Registration Dates
First Submitted
December 30, 2018
First Submitted That Met QC Criteria
January 15, 2019
First Posted (Actual)
January 16, 2019
Study Record Updates
Last Update Posted (Actual)
July 25, 2019
Last Update Submitted That Met QC Criteria
July 24, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P/2019/413
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
interview will be registered then transcribe on professional computer ans accessible only by the investigator and collaborators.
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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