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

Institut Curie

Status: Completed

Conditions: Uveal Melanoma

Treatments: Other: Oncological standard visit; Other: Supportive care visit with questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT04728113

IC 2019-09

Details and patient eligibility

About

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)

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Early together group

Experimental group

Description:

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

Treatment:

Other: Supportive care visit with questionnaires

Other: Oncological standard visit

Control group

Active Comparator group

Description:

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

Treatment:

Other: Oncological standard visit