CompletedNot Applicable

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

France149 participantsStarted 2022-11-28

Plain-language 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 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

FD Qualitative study: notions on quality of life

Timeframe: during group interview (90 minutes)

FD Quantitative study: scores of quality of life and olfaction impairment

Timeframe: during 30 minutes

Trial details

NCT IDNCT05406544

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-11-28

View on ClinicalTrials.gov More Fibrous Dysplasia trials