- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05406544
Df-Life : Quality of Life in Patients With Fibrous Dysplasia (Df-Life)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Roland CHAPURLAT, Pr
- Phone Number: +33 4 72 11 74 82
- Email: roland.chapurlat@chu-lyon.fr
Study Contact Backup
- Name: Blandine MERLE, PhD
- Phone Number: +33 (4) 72 11 74 80
- Email: blandine.merle@inserm.fr
Study Locations
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Lyon, France, 69003
- Edouard Herriot Hospital - rheumatology
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Contact:
- Roland CHAPURLAT, Pr
- Phone Number: +33 4 72 11 74 82
- Email: roland.chapurlat@chu-lyon.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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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.
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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
|
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FD Qualitative study: notions on quality of life
Time Frame: during group interview (90 minutes)
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quality of life concepts that will emerge during group interviews.
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during group interview (90 minutes)
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FD Quantitative study: scores of quality of life and olfaction impairment
Time Frame: during 30 minutes
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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
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during 30 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roland CHAPURLAT, Pr, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL22_0374
- 2022-A01239-34 (Other Identifier: ID RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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