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

NCT ID: NCT04728113

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-16
• Study Completion Date: 2025-01-22

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.

Conditions

Uveal Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Early together group

Oncological standard of care at M0, M3, M6, M9 and M12 with early introduction of supportive care every 6 weeks.

Group Type: EXPERIMENTAL

Supportive care visit with questionnaires

Intervention Type: OTHER

5 Questionnaires (SCNS, QLQ-C30, HADS, PTPQ, GSE) will be filled by the patient with introduction of supportive care visit

Oncological standard visit

Intervention Type: OTHER

Oncological standard visit

Control group

Oncological standard of care at M0, M3, M6, M9 and M12.

Group Type: ACTIVE_COMPARATOR

Oncological standard visit

Intervention Type: OTHER

Oncological standard visit

Interventions

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

Intervention Type: OTHER

Oncological standard visit

Oncological standard visit

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PIPERNO NEUMAN Sophie, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

Centre Antoine Lacassagne

Nice, , France

Institut Curie

Paris, , France

Countries

France

Other Identifiers

IC 2019-09

Identifier Type: -

Identifier Source: org_study_id