Evaluation of a Question Prompt List for Patients With Myelodysplastic Syndromes (QPL-MDS)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a Question Prompt List for Patients With Myelodysplastic Syndromes (QPL-MDS)

Conditions
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Myelodysplastic Syndromes

Intervention / Treatment
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* Behavioral: Question prompt list (QPL)
* Behavioral: Education brochure of Groupe Français des Myélodysplasies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: emergency,patients deprived of liberty or placed under the authority of a tutor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Patients will receive only the education brochure of GFM | Behavioral: Education brochure of Groupe Français des Myélodysplasies<br> <br> |
| Experimental: General QPL group<br>Patients will receive the brochure and the newly developed QPL (general version) | Behavioral: Question prompt list (QPL)<br> <br> Behavioral: Education brochure of Groupe Français des Myélodysplasies<br> <br> |
| Experimental: Targeted QPL group<br>Patients will receive the brochure and the newly developed QPL (general version) | Behavioral: Question prompt list (QPL)<br> <br> Behavioral: Education brochure of Groupe Français des Myélodysplasies<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of questions and concerns expressed in each content category covered by the QPL (including prognosis) | Data collected through the audiotaping of the consultation | 17 months | 
| Duration of the recorded consultation | Data collected through the audiotaping of the consultation | 17 months | 
| Quality of life | Questionnaire | 17 months | 
| Anxiety | Questionnaire | 17 months | 
| Satisfaction with the provided information | Questionnaire | 17 months |