Evaluation of a Question Prompt List for Patients With Myelodysplastic Syndromes (QPL-MDS)
QPL-MDS
1 other identifier
interventional
140
1 country
2
Brief Summary
MDS are a diverse group of hematopoietic malignancies, which mainly occur in patients over 75 years of age. Incidence rate in 2012 in France was more than 6 cases per 100 000 person-years. MDS are characterized by ineffective haematopoiesis causing cytopenia, and by leukemic transformation. The disease is heterogeneous, its pathophysiology complex and clinical evolution variable.The few data available on MDS patients show how difficult it is to understand MDS, its prognosis and the reasons for prescribing or not some treatments. In the context of a highly complex potentially lethal disease such as MDS, it is of utmost importance to optimize the information conveyed to patients. Particularly, 70.5% of MDS patients surveyed in our developmental study would have preferred more information about prognosis at diagnosis disclosure. A simple intervention based on the use of a question prompt list (QPL), would greatly improve the information process by helping patients to express their main concerns at their medical consultations. Cultural differences may exist in the appraisal of QPLs and QPLs have not yet been widely used in France. However, in line with the previous results available in the literature and in a context a priori favourable to the use of such an instrument, the investigators hypothesise that use of a QPL will increase MDS patients' expressions of concerns and questions at their medical consultations. Particularly the investigators assume that the discussion about prognosis will be facilitated, without increasing anxiety because patients remain free to ask or not for such information. The use of QPLs would also be a way to limit social inequalities related to insufficient information and to encourage patient-doctor communication and meeting of patient preferences which could lead to better health outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 18, 2016
CompletedFirst Posted
Study publicly available on registry
May 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedSeptember 5, 2017
September 1, 2017
2 years
May 18, 2016
September 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Patients having discussed as they wished about the prognosis of their MDS in the next medical consultation
The discussion about prognosis will be collected through the audiotaping of the consultation.
17 months
Secondary Outcomes (5)
number of questions and concerns expressed in each content category covered by the QPL (including prognosis)
17 months
Duration of the recorded consultation
17 months
Quality of life
17 months
Anxiety
17 months
Satisfaction with the provided information
17 months
Study Arms (3)
Control group
ACTIVE COMPARATORPatients will receive only the education brochure of GFM
General QPL group
EXPERIMENTALPatients will receive the brochure and the newly developed QPL (general version)
Targeted QPL group
EXPERIMENTALPatients will receive the brochure and the newly developed QPL (general version)
Interventions
Eligibility Criteria
You may qualify if:
- Patients newly referred for a MDS in one of the participating centres
- Older than 18
- Able to answer a self-administered questionnaire
- Having signed an informed consent
- affiliated to the French Social Security System
You may not qualify if:
- emergency,patients deprived of liberty or placed under the authority of a tutor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chu Grenoble
Grenoble, France
Institut Paoli-Calmettes
Marseille, 13009, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jérôme Rey, MD
Institut Paoli-Calmettes
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2016
First Posted
May 24, 2016
Study Start
April 1, 2016
Primary Completion
April 1, 2018
Study Completion
September 1, 2018
Last Updated
September 5, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share