Cutaneous MastocytosisMc_QoLNCT03632811
Adaptation of the Questionnaire "Regarding Patient's Quality of Life With Mastocytosis" in the French Language
An observational study of Cutaneous Mastocytosis and Indolent Systemic Mastocytosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Mastocytosis is a heterogeneous rare disease. A 27-item questionnaire to assess the quality of life of patients with cutaneous/ indolent systemic mastocytosis was developed in the German language and validated in the English language in 2015. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Mastocytosis, Indolent Systemic Mastocytosis
- What is being tested?
- A structured interview with every patient
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2018to 21 Nov 2018
- Phase
- Observational
- 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
Study population: Patient who has indolent cutaneous or systemic mastocytosis
Who may be able to join
- Adult, native French patient with cutaneous or indolent systemic mastocytosis and follow-up at CEREMAST, Toulouse
- Patient having given his agreement of non-opposition
Who cannot join
- Minor patient
- Patient with other forms of mast cell pathology except cutaneous and / or indolent systemic mastocytosis
- Patient with no mast cell pathology
- French non-native patient
- Patient in detention or under guardianship
- Patient not affiliated with Social Security
Trial locations and contacts
1 site in 1 country.
About this study
Mastocytosis is a heterogeneous rare disease. A 27-item questionnaire to assess the quality of life of patients with cutaneous/ indolent systemic mastocytosis was developed in the German language and validated in the English language in 2015.
The team of the University Charité Berlin and the company Moxie - intellectual proprietor of the questionnaire - proposed the use of the recommendations of Baiardini et al. 2010, for linguistic adaptation of this questionnaire in other languages.
Read the detailed description
The first two steps of the program of linguistic translation have already been carried out under the direction and supervision of teams from Charité University, Berlin and Moxie Company. The result of these two steps is a secondary version of the Mc-QoL questionnaire in French. The last step of this adaptation process in the target language (French, France) needs to be carried out and it is the subject of this study.
The objective of this study is the French language adaptation of the Mc-QoL questionnaire in adult patients with indolent cutaneous and / or indolent systemic mastocytosis.
During this study, the second version of the Mc-QoL questionnaire in French will be evaluated on 10 adult patients, with cutaneous and / or indolent systemic mastocytosis and native in the French language. The comprehension tests will be carried out by means of the structured interviews during which the investigator will ask if the patient has had difficulties to understand the recommendations, the questionnaires, will verify the interpretation of all the items and the understanding of each word by the patient. In case of problems, the investigator will propose and / or test translation alternatives, or will ask the patient to propose alternatives.
Revisions to the second version of the Mc-QoL questionnaire in French will be done to rectify the problems identified in the conceptual equivalence. The result will be a third French version of the Mc-QoL questionnaire, which will be the final version.
A report on the interviews will be written in English: it will describe the number of respondents, their age, the time required to complete the questionnaire, the difficulties encountered, the solutions suggested and retained and how the third version of the questionnaire was produced.
- Being tested
- A structured interview with every patient
- Keywords
- cutaneous mastocytosis, indolent systemic mastocytosis, quality of life questionnaire in mastocytosis patient
- Medical subject headings
- Mastocytosis, Cutaneous, Mastocytosis, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A structured interview with every patientOther
The comprehension test will be done through structured interviews in which the principal investigator will ask if the patient has had difficulty understanding the recommendations and questions, will check the interpretation of all items and the understanding of each word by the patient. In case of problems, the investigator will propose and / or test translation alternatives, or will ask the patient to propose alternatives.
What is being measured
The primary outcome is the main question the study is designed to answer.
The understanding of aspects of the questionnaire Mc-QoL
The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient:
- the instructions
Measured: 1 day
The understanding of aspects of the questionnaire Mc-QoL
The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient :
- the questions (items) and the proposed answers
Measured: 1 day
The understanding of aspects of the questionnaire Mc-QoL
The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient :
- the layout of the questionnaire
Measured: 1 day
The understanding of aspects of the questionnaire Mc-QoL
The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient :
- the language (words) used, if it is simple and appropriate
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start14 Nov 2018
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MastocytosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Bulai Livideanu, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632811
- Sponsor's protocol ID
- RC31/18/0303
- Other IDs
- 2018-A02213-52
- Acronym
- Mc_QoL
- Status last verified
- Jul 2019
- First submitted
- 13 Aug 2018
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the Questionnaire "Regarding Patient's Quality of Life With Mastocytosis" in the French Language
- ClinicalTrials.gov ID
- NCT03632811
- Acronym / sponsor ID
- Mc_QoL / RC31/18/0303
- Keywords
- cutaneous mastocytosis, indolent systemic mastocytosis, quality of life questionnaire in mastocytosis patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 15 Aug 2018 (actual)
- 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.
Mastocytosis is a heterogeneous rare disease. A 27-item questionnaire to assess the quality of life of patients with cutaneous/ indolent systemic mastocytosis was developed in the German language and validated in the English language in 2015.
The team of the University Charité Berlin and the company Moxie - intellectual proprietor of the questionnaire - proposed the use of the recommendations of Baiardini et al. 2010, for linguistic adaptation of this questionnaire in other languages.
Detailed description
The first two steps of the program of linguistic translation have already been carried out under the direction and supervision of teams from Charité University, Berlin and Moxie Company. The result of these two steps is a secondary version of the Mc-QoL questionnaire in French. The last step of this adaptation process in the target language (French, France) needs to be carried out and it is the subject of this study.
The objective of this study is the French language adaptation of the Mc-QoL questionnaire in adult patients with indolent cutaneous and / or indolent systemic mastocytosis.
During this study, the second version of the Mc-QoL questionnaire in French will be evaluated on 10 adult patients, with cutaneous and / or indolent systemic mastocytosis and native in the French language. The comprehension tests will be carried out by means of the structured interviews during which the investigator will ask if the patient has had difficulties to understand the recommendations, the questionnaires, will verify the interpretation of all the items and the understanding of each word by the patient. In case of problems, the investigator will propose and / or test translation alternatives, or will ask the patient to propose alternatives.
Revisions to the second version of the Mc-QoL questionnaire in French will be done to rectify the problems identified in the conceptual equivalence. The result will be a third French version of the Mc-QoL questionnaire, which will be the final version.
A report on the interviews will be written in English: it will describe the number of respondents, their age, the time required to complete the questionnaire, the difficulties encountered, the solutions suggested and retained and how the third version of the questionnaire was produced.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who has indolent cutaneous or systemic mastocytosis
Key inclusion criteria (2 listed)
- Adult, native French patient with cutaneous or indolent systemic mastocytosis and follow-up at CEREMAST, Toulouse
- Patient having given his agreement of non-opposition
Key exclusion criteria (6 listed)
- Minor patient
- Patient with other forms of mast cell pathology except cutaneous and / or indolent systemic mastocytosis
- Patient with no mast cell pathology
- French non-native patient
- Patient in detention or under guardianship
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 |
|---|---|---|
| A structured interview with every patientThe comprehension test will be done through structured interviews in which the principal investigator will ask if the patient has had difficulty understanding the recommendations and questions, will check the interpretation of all items and the understanding of each word by the patient. In case of problems, the investigator will propose and / or test translation alternatives, or will ask the patient to propose alternatives. | Other | – |
Primary outcome
The understanding of aspects of the questionnaire Mc-QoL
Time frame: 1 day
The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient: - the instructions
The understanding of aspects of the questionnaire Mc-QoL
Time frame: 1 day
The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient : - the questions (items) and the proposed answers
The understanding of aspects of the questionnaire Mc-QoL
Time frame: 1 day
The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient : - the layout of the questionnaire
The understanding of aspects of the questionnaire Mc-QoL
Time frame: 1 day
The understanding of aspects of the questionnaire Mc-QoL (version "secondary" in French) will be evaluated for each patient : - the language (words) used, if it is simple and appropriate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Cristina Bulai Livideanu, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Mastocytosis and Indolent Systemic Mastocytosis, run by University Hospital, Toulouse at 1 site 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The understanding of aspects of the questionnaire Mc-QoL (time frame: 1 day). The study lists 4 primary outcomes in all. 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 17 Jul 2019.