Fibrous DysplasiaDf-LifeNCT05406544
Df-Life : Quality of Life in Patients With Fibrous Dysplasia
An observational study of Fibrous Dysplasia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Fibrous dysplasia (FD) is a congenital skeletal disorder with multiple complications such as bone pain, fractures, deformities and nerve compression. Few quantitative studies have demonstrated its physical, mental and social negative impacts on patients but none have qualitatively evaluated their global quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrous Dysplasia
- What is being tested?
- FD qualitative study on quality of life and FD quantitative sudy on quality of life and olfaction.
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2022to 2 May 2023
- 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: Primary care clinics: adults coming for consultation or hospitalization for fibrous dysplasia in Hopital Edouard Herriot rheumatology department in Lyon, France.
Who may be able to join
- Men and women
- 18 years and more
- with Fibrous dysplasia
- Being followed in the rheumatology Department of the E. Herriot Hospital in Lyon.
- Non-opposition to take part in the study
- written consent to the audio recording of the discussions.
Who cannot join
- Legal incapacity or limited legal capacity
- Psychiatric or neurological condition that severely impairs comprehension
- Difficulty understanding spoken French
- Patients with another pathology with a major impact on quality of life
Trial locations and contacts
1 site in 1 country.
About this study
Fibrous dysplasia (FD) is a congenital skeletal disorder with multiple complications such as bone pain, fractures, deformities and nerve compression. Few quantitative studies have demonstrated its physical, mental and social negative impacts on patients but none have qualitatively evaluated their global quality of life. Our hypothesis is that a better knowledge of the quality of life of FD patients should allow to target the actions to be implemented to improve patients'care.
The main objective of this qualitative research is therefore to investigate the quality of life of FD patients through 2 approaches: a qualitative study with focus groups interviews addressing several themes: self-image, psychological and emotional well-being, difficulties and adaptative strategies; and a quantitative study to measure the impact of FD on quality of life and on olfaction (sometimes affected by nerve compression due to the disease) using standardized questionnaires Short Form 36 (SF36) and Self-reported Mini Olfactory Questionnaire (SELF-MOQ).
- Conditions
- Fibrous Dysplasia
- Being tested
- FD qualitative study on quality of life, FD quantitative sudy on quality of life and olfaction.
- Keywords
- Fibrous dysplasia, quality of life
- Medical subject headings
- Fibrous Dysplasia of Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FD qualitative study on quality of lifeOther
Patients will be contacted and focus groups will be organized with 6 to 8 patients presenting different types of FD: monostotic, polyostotic, with or without craniofacial damage. Several focus-groups will be conducted with men only or women only. Patients will be led in a semi-directive manner by a moderator who will use an interview grid listing all the topics to be addressed: symptoms, self-image, psychological and emotional well-being, difficulties in daily life and adaptative strategies. The discussions will be recorded and transcribed verbatim. Data will be analyzed manually by 2 investigators and with the help of a semantic analysis software. The objective is to bring out common notions about the quality of life of patients, their psychological and emotional well-being, their difficulties in daily life and their coping strategies according to their condition. Differences or similarities between men and women will be investigated.
FD quantitative sudy on quality of life and olfaction.Other
Participants will receive 3 questionnaires to complete: the SF36 questionnaire (quality of life), the SELF-MOQ questionnaire (olfaction evaluation) and a demographic questionnaire. Other data required for the study will be extracted from the medical record: age, weight, height, affected bone sites, Radiological/ biological activity data, sensorial deficit, medication. For each questionnaire, scores will be calculated and compared between the different FD patient populations according to sex, age and type of FD.
| Study group | Role | What they receive |
|---|---|---|
| FD qualitative study on quality of life. | FD patients (FD monostotic, FD polyostotic, with or without craniofacial damages) will be invited to attend a focus group on the following themes: symptoms, self-image, psychological and emotional well-being, difficulties in daily life and adaptative strategies. The focus-groups will be conducted in a semi-directive manner by a moderator and will be recorded; after a verbatim transcription of the focus group recordings, the data will be analyzed manually and with the help of a semantic analysis software. It will allow common notions about quality of life in FD to emerge. A demographic questionnaire will also be completed by the participants. Receives: Other: FD qualitative study on quality of life | |
| FD quantitative sudy on quality of life and olfaction. | Participants will receive two questionnaires to complete: the SF36 questionnaire (quality of life) and the SELF-MOQ questionnaire (olfaction impairment evaluation). Other data required for the study will be extracted from the medical record: age, weight, height, affected bone sites, Radiological/ biological activity data, sensorial deficit, medication. A demographic questionnaire will also be completed. Receives: Other: FD quantitative sudy on quality of life and olfaction. | |
| FD qualitative and quantitative study on quality of life and olfaction. | Patients will be invited to attend a focus group on quality of life (qualitative study) as described for group 1 and to complete questionnaires on quality of life and olfaction (quantitative study) as described for group 2 Receives: Other: FD qualitative study on quality of life; Other: FD quantitative sudy on quality of life and olfaction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FD Qualitative study: notions on quality of life
quality of life concepts that will emerge during group interviews.
Measured: during group interview (90 minutes)
FD Quantitative study: scores of quality of life and olfaction impairment
quality of life measured with SF36 score. Patients will answer to 11 questions. Olfaction impairment measured with SELF-MOQ olfaction score. Patients will answer to 14 questions
Measured: during 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start28 Nov 2022
- Primary completion28 Nov 2022
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrous DysplasiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland CHAPURLAT, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406544
- Sponsor's protocol ID
- 69HCL22_0374
- Other IDs
- 2022-A01239-34
- Acronym
- Df-Life
- Status last verified
- Mar 2024
- First submitted
- 2 Jun 2022
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Df-Life : Quality of Life in Patients With Fibrous Dysplasia
- ClinicalTrials.gov ID
- NCT05406544
- Acronym / sponsor ID
- Df-Life / 69HCL22_0374
- Conditions
- Fibrous Dysplasia
- Keywords
- Fibrous dysplasia, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 6 Jun 2022 (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.
Fibrous dysplasia (FD) is a congenital skeletal disorder with multiple complications such as bone pain, fractures, deformities and nerve compression. Few quantitative studies have demonstrated its physical, mental and social negative impacts on patients but none have qualitatively evaluated their global quality of life. Our hypothesis is that a better knowledge of the quality of life of FD patients should allow to target the actions to be implemented to improve patients'care.
The main objective of this qualitative research is therefore to investigate the quality of life of FD patients through 2 approaches: a qualitative study with focus groups interviews addressing several themes: self-image, psychological and emotional well-being, difficulties and adaptative strategies; and a quantitative study to measure the impact of FD on quality of life and on olfaction (sometimes affected by nerve compression due to the disease) using standardized questionnaires Short Form 36 (SF36) and Self-reported Mini Olfactory Questionnaire (SELF-MOQ).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FD qualitative study on quality of life. | – | Other: FD qualitative study on quality of lifeFD patients (FD monostotic, FD polyostotic, with or without craniofacial damages) will be invited to attend a focus group on the following themes: symptoms, self-image, psychological and emotional well-being, difficulties in daily life and adaptative strategies. The focus-groups will be conducted in a semi-directive manner by a moderator and will be recorded; after a verbatim transcription of the focus group recordings, the data will be analyzed manually and with the help of a semantic analysis software. It will allow common notions about quality of life in FD to emerge. A demographic questionnaire will also be completed by the participants. |
| FD quantitative sudy on quality of life and olfaction. | – | Other: FD quantitative sudy on quality of life and olfaction.Participants will receive two questionnaires to complete: the SF36 questionnaire (quality of life) and the SELF-MOQ questionnaire (olfaction impairment evaluation). Other data required for the study will be extracted from the medical record: age, weight, height, affected bone sites, Radiological/ biological activity data, sensorial deficit, medication. A demographic questionnaire will also be completed. |
| FD qualitative and quantitative study on quality of life and olfaction. | – | Other: FD qualitative study on quality of life, Other: FD quantitative sudy on quality of life and olfaction.Patients will be invited to attend a focus group on quality of life (qualitative study) as described for group 1 and to complete questionnaires on quality of life and olfaction (quantitative study) as described for group 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinics: adults coming for consultation or hospitalization for fibrous dysplasia in Hopital Edouard Herriot rheumatology department in Lyon, France.
Key inclusion criteria (6 listed)
- Men and women
- 18 years and more
- with Fibrous dysplasia
- Being followed in the rheumatology Department of the E. Herriot Hospital in Lyon.
- Non-opposition to take part in the study
Key exclusion criteria (4 listed)
- Legal incapacity or limited legal capacity
- Psychiatric or neurological condition that severely impairs comprehension
- Difficulty understanding spoken French
- Patients with another pathology with a major impact on quality of life
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 |
|---|---|---|
| FD qualitative study on quality of lifePatients will be contacted and focus groups will be organized with 6 to 8 patients presenting different types of FD: monostotic, polyostotic, with or without craniofacial damage. Several focus-groups will be conducted with men only or women only. Patients will be led in a semi-directive manner by a moderator who will use an interview grid listing all the topics to be addressed: symptoms, self-image, psychological and emotional well-being, difficulties in daily life and adaptative strategies. The discussions will be recorded and transcribed verbatim. Data will be analyzed manually by 2 investigators and with the help of a semantic analysis software. The objective is to bring out common notions about the quality of life of patients, their psychological and emotional well-being, their difficulties in daily life and their coping strategies according to their condition. Differences or similarities between men and women will be investigated. | Other | FD qualitative and quantitative study on quality of life and olfaction., FD qualitative study on quality of life. |
| FD quantitative sudy on quality of life and olfaction.Participants will receive 3 questionnaires to complete: the SF36 questionnaire (quality of life), the SELF-MOQ questionnaire (olfaction evaluation) and a demographic questionnaire. Other data required for the study will be extracted from the medical record: age, weight, height, affected bone sites, Radiological/ biological activity data, sensorial deficit, medication. For each questionnaire, scores will be calculated and compared between the different FD patient populations according to sex, age and type of FD. | Other | FD qualitative and quantitative study on quality of life and olfaction., FD quantitative sudy on quality of life and olfaction. |
Primary outcome
FD Qualitative study: notions on quality of life
Time frame: during group interview (90 minutes)
quality of life concepts that will emerge during group interviews.
FD Quantitative study: scores of quality of life and olfaction impairment
Time frame: during 30 minutes
quality of life measured with SF36 score. Patients will answer to 11 questions. Olfaction impairment measured with SELF-MOQ olfaction score. Patients will answer to 14 questions
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 22 Mar 2024.
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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.
Roland CHAPURLAT, Pr principal investigator
Hospices Civils de Lyon
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 Fibrous Dysplasia, run by Hospices Civils de Lyon 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 6 inclusion and 4 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 22 Mar 2024. 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?
FD Qualitative study: notions on quality of life (time frame: during group interview (90 minutes)). The study lists 2 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 22 Mar 2024.