Df-Life : Quality of Life in Patients With Fibrous Dysplasia

Civil Hospices of Lyon

Status: Completed

Conditions: Fibrous Dysplasia

Treatments: Other: FD quantitative sudy on quality of life and olfaction.; Other: FD qualitative study on quality of life

Study type: Observational

Funder types: Other

Identifiers

NCT05406544

69HCL22_0374

2022-A01239-34 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

149 participants in 3 patient groups

FD qualitative study on quality of life.

Description:

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.

Treatment:

Other: FD qualitative study on quality of life

FD quantitative sudy on quality of life and olfaction.

Description:

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.

Treatment:

Other: FD quantitative sudy on quality of life and olfaction.

FD qualitative and quantitative study on quality of life and olfaction.

Description:

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

Treatment:

Other: FD qualitative study on quality of life

Other: FD quantitative sudy on quality of life and olfaction.