Evaluation of the Variation in Quality of Life During Medical Transition for Transgender People.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gender Dysphoria. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Variation in Quality of Life During Medical Transition According Different Modalities of Supported Care for Transgender People.
Overview
Transgender people can benefit from psychological, psychiatric, endocrinological support, sexual reassignment surgery, sexology support and dermatological care. The value of transitional care courses is scientifically recognized. Currently, the modalities of decision and realization of the care paths are heterogeneous on the territory, little standardized, and are the subject of debates between representatives of users and medical teams. The french national report of IGAS from 2011 warns of the need to argue and legitimize care practices through more numerous, more exhaustive scientific studies, presenting a better level of evidence Since 2011, no prospective study has been carried out on the national and international level, making it possible to assess the relevance of the planned care modalities. This research project, conducted over five consecutive years at the first contact of a transgender people with a care device, aims to correlate a variation in the quality of life of people with the characteristics of the care methods provided. This is a first proposal to assess care practices for transgender people. The results of this study would first allow us to infer the care modalities most suited to the needs of people. Secondly, secondary hypotheses could support new experimental protocols.
Detailed description
This research is a prospective multicenter cohort study with a 3-year and 5-year follow-up of transgender people in medical transition.
Main aim:
Evaluate the evolution of the quality of life during five years in transgender people who benefit from transition support cares.
Secondary objectives:
Secondary objective n°1 :
Identify the different factors that influence the evolution of quality of life evaluated over three years in transgender people who benefit from transition support cares.
Secondary objective n°2 :
Evaluate the evolution of the satisfaction of the shared medical decision for transgender people in medical transition.
Secondary objective n°3 :
Evaluate the evolution of the satisfaction of body image for transgender people in medical transition.
Secondary objective n°4 :
Evaluate the evolution of psychiatric comorbidities for transgender people in medical transition.
Secondary objective n°5 :
Evaluate the benefits and limits in long term (five years) on the quality of life, the satisfaction of the shared medical decision, the satisfaction of body image and the evolution of psychiatric comorbidities.
Primary outcome measures
- Quality of life scores [Time frame: 3 years]
Secondary outcome measures (6)
- Social factors (age, gender, profession, knowledge of care system) [Time frame: Baseline and 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years]
- Satisfaction of the shared medical decision [Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years]
- Satisfaction of body image [Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years]
- General psychopathology [Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years]
- Anxiety and depression [Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years]
- Quality of life scores [Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 5 years]
Eligibility criteria
Inclusion criteria
- With a diagnosis of Gender Dysphoria according to DSM5 diagnostic criteria
- Wishing to benefit from supportive care for their transition trajectory and addressing a care system represented by the collaborating centers participating in the study,
- Willing to comply with all study procedures and duration,
- Understanding and able to speak French.
Exclusion criteria
- Minor or adult under curatorship, under judicial protection, persons deprived of their liberty
- Refusal to participate after clear and fair information from the study
- Person with sexual reassignment surgery or with cross hormon therapy since two years.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 13 centers
- Centre Hospitalier de Béziers — Béziers
- CHU de Bordeaux — Bordeaux
- CHU de Brest — Brest
- CHU de Caen — Caen
- CHU de Lille — Lille
- Maison de Santé Lille Moulins — Lille
- Maison de Santé Lille Sud — Lille
- CHU de Lyon — Lyon
- … and 5 more centers
Identifiers
NCT: NCT05273112 · 2020_09 · 2021-A00154-37 · PREPS-19-0078