NCT03806712

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 30, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

December 30, 2018

Last Update Submit

July 24, 2019

Conditions

Keywords

social representation

Outcome Measures

Primary Outcomes (1)

  • measure the impact of social representation on platelet transfusion practice

    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

Study Arms (3)

patient

patient with advanced, non curative hematological malignancies multi method questionary, at least 1 hour per patient

Other: multi method questionary (developped by De Rosa, in 1995 and 2014)

hematologist

medical practitioner of platelet transfusion multi method questionary, at least 1 hour per hematologist

Other: multi method questionary (developped by De Rosa, in 1995 and 2014)

Nurses

nurses working in hematology, practicing platelet transfusion multi method questionary, at least 1 hour per nurse

Other: multi method questionary (developped by De Rosa, in 1995 and 2014)

Interventions

questions from an association network according to the subject and the grounded theorise (Glasser and Strauss)

Nurseshematologistpatient

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • minor patient
  • non communicant patient
  • non transfused platelet patient
  • non voluntary patient or hematologist or nurses
  • non graduated hematologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moracchini

Besançon, 25000, France

Location

Related Publications (3)

  • 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.

    PMID: 18810505BACKGROUND
  • 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.

    PMID: 17371426BACKGROUND
  • 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.

    PMID: 26796561BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

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

Study Record Dates

First Submitted

December 30, 2018

First Posted

January 16, 2019

Study Start

April 1, 2019

Primary Completion

June 1, 2019

Study Completion

July 22, 2019

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

interview will be registered then transcribe on professional computer ans accessible only by the investigator and collaborators.

Locations