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

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.

Study Overview

• Status: Unknown
• Conditions: Myelodysplastic Syndromes
• Intervention / Treatment: Behavioral: Education brochure of Groupe Français des Myélodysplasies; Behavioral: Question prompt list (QPL)

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • Recruiting
    • CHU Grenoble
    • Contact: Sophe PARK, MD,PhD; Email: spark@chu-grenoble.fr
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli-Calmettes
    • Contact: Jérôme REY, MD; Phone Number: 0033491223696
    • Sub-Investigator: Norbert VEY, MD
    • Sub-Investigator: Bilal MOHTY, MD
    • Principal Investigator: Jérôme REY, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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: Education brochure of Groupe Français des Myélodysplasies; Behavioral: Question prompt list (QPL)
EXPERIMENTAL: Targeted QPL group; Patients will receive the brochure and the newly developed QPL (general version)	Behavioral: Education brochure of Groupe Français des Myélodysplasies; Behavioral: Question prompt list (QPL)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Jérôme Rey, MD, Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ANTICIPATED): April 1, 2018
• Study Completion (ANTICIPATED): September 1, 2018

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (ESTIMATE): May 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: QPL-MDS-IPC 2014-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO