Clinical trial NCT05273112: Evaluation of the Variation in Quality of Life During Medical Transition for Transgender People.
Official title: Evaluation of the Variation in Quality of Life During Medical Transition According Different Modalities of Supported Care for Transgender People.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gender Dysphoria
Keywords: Transidentity
Gender Dysphoria
Transition
Quality of Life
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: transgender people in medical transition

Brief summary: 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.

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.

Primary outcomes:
measure: Quality of life scores
timeFrame: 3 years
Secondary outcomes:
measure: Social factors (age, gender, profession, knowledge of care system)
timeFrame: Baseline and 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
measure: Satisfaction of the shared medical decision
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
measure: Satisfaction of body image
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
measure: General psychopathology
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
measure: Anxiety and depression
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
measure: Quality of life scores
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 5 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHU de Brest
city: Béziers
country: France
facility: Centre Hospitalier de Béziers
city: Caen
country: France
facility: CHU de Caen
city: Lille
country: France
facility: CHU de Lille
city: Lille
country: France
facility: Maison de Santé Lille Moulins
city: Lille
country: France
facility: Maison de Santé Lille Sud
city: Lyon
country: France
facility: CHU de Lyon
city: Lyon
country: France
facility: G..R.E.T.T.I.S
city: Marseille
country: France
facility: Hopital de la Conception - Marseille
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Centre Hospitalier Maison Blanche
city: Paris
country: France
facility: Centre Hospitalier Sainte-Anne
Study officials:
affiliation: University Hospital, Lille
name: François MEDJKANE, MD
role: PRINCIPAL_INVESTIGATOR
References: