Myelodysplastic SyndromesQPL-MDSNCT02781441
Evaluation of a Question Prompt List for Patients With Myelodysplastic Syndromes (QPL-MDS)
A study testing Question prompt list (QPL) and Education brochure of Groupe Français des Myélodysplasies in people with Myelodysplastic Syndromes, run by Institut Paoli-Calmettes at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Question prompt list (QPL) and Education brochure of Groupe Français des Myélodysplasies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- emergency,patients deprived of liberty or placed under the authority of a tutor
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Chu Grenoble
Grenoble
Sophe PARK, MD,PhD, spark@chu-grenoble.fr
- Recruiting
Institut Paoli-Calmettes
Marseille, 13009
Jérôme REY, MD, 0033491223696
Jihane PAKRADOUNI, PharmD PhD, 0033491223778, drci.up@ipc.unicancer.fr
About this study
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.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Question prompt list (QPL), Education brochure of Groupe Français des Myélodysplasies
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Question prompt list (QPL)Behavioural
Education brochure of Groupe Français des MyélodysplasiesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients will receive only the education brochure of GFM Receives: Behavioral: Education brochure of Groupe Français des Myélodysplasies |
| General QPL group | Experimental | Patients will receive the brochure and the newly developed QPL (general version) Receives: Behavioral: Question prompt list (QPL); Behavioral: Education brochure of Groupe Français des Myélodysplasies |
| Targeted QPL group | Experimental | Patients will receive the brochure and the newly developed QPL (general version) Receives: Behavioral: Question prompt list (QPL); Behavioral: Education brochure of Groupe Français des Myélodysplasies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 months
Secondary outcomes (5)
number of questions and concerns expressed in each content category covered by the QPL (including prognosis)
Data collected through the audiotaping of the consultation
Measured: 17 months
Duration of the recorded consultation
Data collected through the audiotaping of the consultation
Measured: 17 months
Quality of life
Questionnaire
Measured: 17 months
Anxiety
Questionnaire
Measured: 17 months
Satisfaction with the provided information
Questionnaire
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme Rey, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781441
- Sponsor's protocol ID
- QPL-MDS-IPC 2014-013
- Acronym
- QPL-MDS
- Status last verified
- Sep 2017
- First submitted
- 18 May 2016
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Question Prompt List for Patients With Myelodysplastic Syndromes (QPL-MDS)
- ClinicalTrials.gov ID
- NCT02781441
- Acronym / sponsor ID
- QPL-MDS / QPL-MDS-IPC 2014-013
- Conditions
- Myelodysplastic Syndromes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 24 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Education brochure of Groupe Français des MyélodysplasiesPatients will receive only the education brochure of GFM |
| General QPL group | Experimental | Behavioral: Question prompt list (QPL), Behavioral: Education brochure of Groupe Français des MyélodysplasiesPatients will receive the brochure and the newly developed QPL (general version) |
| Targeted QPL group | Experimental | Behavioral: Question prompt list (QPL), Behavioral: Education brochure of Groupe Français des MyélodysplasiesPatients will receive the brochure and the newly developed QPL (general version) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- emergency,patients deprived of liberty or placed under the authority of a tutor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Question prompt list (QPL) | Behavioural | General QPL group, Targeted QPL group |
| Education brochure of Groupe Français des Myélodysplasies | Behavioural | Control group, General QPL group, Targeted QPL group |
Primary outcome
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.
5 secondary outcomes
number of questions and concerns expressed in each content category covered by the QPL (including prognosis)
Time frame: 17 months
Duration of the recorded consultation
Time frame: 17 months
Quality of life
Time frame: 17 months
Anxiety
Time frame: 17 months
Satisfaction with the provided information
Time frame: 17 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Individual participant dataSharing planned: No
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Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
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Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
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Myelodysplastic Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme Rey, MD principal investigator
Institut Paoli-Calmettes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Question prompt list (QPL) and Education brochure of Groupe Français des Myélodysplasies in people with Myelodysplastic Syndromes, run by Institut Paoli-Calmettes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENRE, MD (0033491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients having discussed as they wished about the prognosis of their MDS in the next medical consultation (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017; AzTrials last refreshed its copy on 7 Nov 2026.