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

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ClinicalTrials.gov Identifier: NCT02781441
Recruitment Status : Recruiting
First Posted : May 24, 2016
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

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.


Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Behavioral: Question prompt list (QPL) Behavioral: Education brochure of Groupe Français des Myélodysplasies Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Question Prompt List for Patients With Myelodysplastic Syndromes (QPL-MDS)
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Patients having discussed as they wished about the prognosis of their MDS in the next medical consultation [ Time Frame: 17 months ]
    The discussion about prognosis will be collected through the audiotaping of the consultation.


Secondary Outcome Measures :
  1. number of questions and concerns expressed in each content category covered by the QPL (including prognosis) [ Time Frame: 17 months ]
    Data collected through the audiotaping of the consultation

  2. Duration of the recorded consultation [ Time Frame: 17 months ]
    Data collected through the audiotaping of the consultation

  3. Quality of life [ Time Frame: 17 months ]
    Questionnaire

  4. Anxiety [ Time Frame: 17 months ]
    Questionnaire

  5. Satisfaction with the provided information [ Time Frame: 17 months ]
    Questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781441


Contacts
Contact: Dominique GENRE, MD 0033491223778 drci.up@ipc.unicancer.fr
Contact: Jihane PAKRADOUNI, PharmD PhD 0033491223778 drci.up@ipc.unicancer.fr

Locations
France
Chu Grenoble Recruiting
Grenoble, France
Contact: Sophe PARK, MD,PhD       spark@chu-grenoble.fr   
Institut Paoli-Calmettes Recruiting
Marseille, France, 13009
Contact: Jérôme REY, MD    0033491223696      
Contact: Jihane PAKRADOUNI, PharmD PhD    0033491223778    drci.up@ipc.unicancer.fr   
Sub-Investigator: Norbert VEY, MD         
Sub-Investigator: Bilal MOHTY, MD         
Sub-Investigator: Aude CHARBONNIER, MD         
Principal Investigator: Jérôme REY, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Jérôme Rey, MD Institut Paoli-Calmettes

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT02781441     History of Changes
Other Study ID Numbers: QPL-MDS-IPC 2014-013
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms