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

Gender Dysphoria Clinical Trial

— TRANS'ITION  

Official title:

Evaluation of the Variation in Quality of Life During Medical Transition According Different Modalities of Supported Care for Transgender People.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05273112
• Other study ID #: 2020_09
• Secondary ID: 2021-A00154-37PR
• Status: Not yet recruiting
• Start date: April 2023
• Est. completion date: April 2030

Study information

• Verified date: November 2022
• Source: University Hospital, Lille
• Contact: François MEDJKANE, MD
• Phone: 0320445962
• Email: francois.medjkane[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: April 2030
• Est. primary completion date: April 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gender Dysphoria

Locations

Country	Name	City	State
France	Centre Hospitalier de Béziers	Béziers
France	CHU de Bordeaux	Bordeaux
France	CHU de Brest	Brest
France	CHU de Caen	Caen
France	CHU de Lille	Lille
France	Maison de Santé Lille Moulins	Lille
France	Maison de Santé Lille Sud	Lille
France	CHU de Lyon	Lyon
France	G..R.E.T.T.I.S	Lyon
France	Hopital de la Conception - Marseille	Marseille
France	CHU de Nice	Nice
France	Centre Hospitalier Maison Blanche	Paris
France	Centre Hospitalier Sainte-Anne	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life scores	Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale	3 years
Secondary	Social factors (age, gender, profession, knowledge of care system)	Answers given by the patient during interview	Baseline and 6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Secondary	Satisfaction of the shared medical decision	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)	6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Secondary	Satisfaction of body image	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	6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Secondary	General psychopathology	French version of Mini International Neuropsychiatric Interview (DSM)	6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Secondary	Anxiety and depression	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	6 months, 12 months, 18 months, 24 months, 30 months, 3 years and 5 years
Secondary	Quality of life scores	Scores on the WHOQOL BREF (World Health Organisation Quality Of Life) scale	6 months, 12 months, 18 months, 24 months, 30 months, 5 years