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

Not Applicable

Completed

• Conditions: Uveal Melanoma
• Interventions: Other: Supportive care visit with questionnaires; Other: Oncological standard visit

• Registration Number: NCT04728113
• Lead Sponsor: Institut Curie

Brief 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.

Study Timeline

• Study Start: 2020-07-16
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-28
• Primary Completion: 2025-01-22
• Study Completion: 2025-01-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

1. adult patients with metastatic UM;
2. no surgery or loco-regional treatment of metastases in a curative intent;
3. systemic treatment planned or started since less than 2 months;
4. ECOG PS 0-1;
5. no uncontrolled symptoms;
6. liver function tests in normal range or ≤ grade 2;
7. signed informed consent;
8. able to fill the questionnaires.

Exclusion Criteria

1. patient<18 years old;
2. patient condition requiring supportive care before any systemic specific treatment for metastases;
3. acute psychopathological disorder incompatible with the study;
4. prior medical condition incompatible with the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early together group	Oncological standard visit	Oncological standard of care at M0, M3, M6, M9 and M12 with early introduction of supportive care every 6 weeks.
Early together group	Supportive care visit with questionnaires	Oncological standard of care at M0, M3, M6, M9 and M12 with early introduction of supportive care every 6 weeks.
Control group	Oncological standard visit	Oncological standard of care at M0, M3, M6, M9 and M12.

Primary Outcome Measures

Name	Time	Method
34 items - Supportive Care Needs Survey	6 months	The main study criterion is the score to the "Care and Support Needs" domain (items 18-22) of the SCNS-SF34 questionnaire obtained in the two arms at 6 months after inclusion. A 10 points mean score difference expected between groups. Each question is ranged from 0 (no need of supportive care) to 5 (strong need of supportive care). Scores for Outcome 1 may vary from 0 to 25.

Trial Locations

Locations (2)

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Institut Curie; 🇫🇷 Paris, France