NCT04728113

Early Integration of Supportive Care for Metastatic Uveal Melanoma Patients (EarlyTogether)

Early Integration of Supportive Care Into Standard Oncology Care for Metastatic Uveal Melanoma Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study main objective is to assess whether the early introduction of supportive care demonstrates a benefit on patients' psychological care needs at 6 months (M6), versus oncological standard of care in patients with metastatic UM. Supportive care in patients with metastatic Uveal Melanoma (UM)

Detailed description

Before the start of the study, medical oncologists and supportive care physicians from both the sites will attend Communication Skills Training (CST) workshops provided by an expert team in the field. The training sessions will focus on practicing the required communication skills needed in consultations. The randomization will assign patients, with a 1:2 ratio, to "Introduction of supportive care when medically needed" (Arm A: Control Group) or "Initial concomitant management by the oncologist and the supportive care team" (Arm B: Early Together Group). Selected and validated questionnaires will be filled at baseline, 6 and 12 months by the patients before the consultation, in the 2 groups.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
OTHER	Supportive care visit with questionnaires	5 Questionnaires (SCNS, QLQ-C30, HADS, PTPQ, GSE) will be filled by the patient with introduction of supportive care visit
OTHER	Oncological standard visit	Oncological standard visit

Timeline

• Start date: 2020-07-16
• Primary completion: 2025-01-22
• Completion: 2025-01-22
• First posted: 2021-01-28
• Last updated: 2025-09-08

Locations

2 sites across 1 country: France