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

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).

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Key information

Conditions

Fibrous Dysplasia Bone Diseases Bone Diseases, Developmental Fibrous Dysplasia of Bone Musculoskeletal Diseases Osteochondrodysplasias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Edouard Herriot Hospital - rheumatology

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FD qualitative study on quality of life

Other

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: Df-Life

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Jun 6, 2022
Registry last updated: Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed