Evaluation of the Variation in Quality of Life During Medical Transition for Transgender People.

Not yet recruiting

• Conditions: Gender Dysphoria

• Registration Number: NCT05273112
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-10
• Status Verified: 2022-11
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10
• Study Start: 2023-04
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life scores	3 years	Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale

Secondary Outcome Measures

Name	Time	Method
Social factors (age, gender, profession, knowledge of care system)	Baseline and 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years	Answers given by the patient during interview
Satisfaction of the shared medical decision	6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years	Scores on the CDIS (Clinical Decision-making Involvement and Satisfaction) clinical decision making involvement and satisfaction score 15 questions scored 1-5 (totally disagree, strongly disagree, neither agree nor disagree, strongly agree, totally agree)
Satisfaction of body image	6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years	Score on the BIS (Body Image Scale), total score ranges from 0 to 30, A higher score means a higher level of body image disturbance
General psychopathology	6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years	French version of Mini International Neuropsychiatric Interview (DSM)
Anxiety and depression	6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years	Anxiety and depression scores on the HAD scale (Hospital Anxiety and Depression scale), a score upper 8 means is considered as a risk of an anxiety or depressive disorder
Quality of life scores	6 months, 12 months, 18 months, 24 months, 30 months, 5 years	Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale

Trial Locations

Locations (13)

CHU de Brest; 🇫🇷 Brest, France

CHU de Lyon; 🇫🇷 Lyon, France

Maison de Santé Lille Moulins; 🇫🇷 Lille, France

G..R.E.T.T.I.S; 🇫🇷 Lyon, France

Centre Hospitalier Maison Blanche; 🇫🇷 Paris, France

CHU de Lille; 🇫🇷 Lille, France

Maison de Santé Lille Sud; 🇫🇷 Lille, France

CHU de Caen; 🇫🇷 Caen, France

CHU de Nice; 🇫🇷 Nice, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Centre Hospitalier de Béziers; 🇫🇷 Béziers, France

Hopital de la Conception - Marseille; 🇫🇷 Marseille, France

Centre Hospitalier Sainte-Anne; 🇫🇷 Paris, France