NCT05273112

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gender Dysphoria

Timeline

• Start date: 2023-04-01
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2022-03-10
• Last updated: 2023-02-10

Locations

13 sites across 1 country: France