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

Study Overview
=================
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.

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

Conditions
-----------------
Uveal Melanoma

Intervention / Treatment
-----------------
* Other: Supportive care visit with questionnaires
* Other: Oncological standard visit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with metastatic UM; no surgery or loco-regional treatment of metastases in a curative intent; systemic treatment planned or started since less than 2 months; ECOG PS 0-1; no uncontrolled symptoms; liver function tests in normal range or ≤ grade 2; signed informed consent; able to fill the questionnaires. Exclusion Criteria: patient<18 years old; patient condition requiring supportive care before any systemic specific treatment for metastases; acute psychopathological disorder incompatible with the study; prior medical condition incompatible with the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early together group<br>Oncological standard of care at M0, M3, M6, M9 and M12 with early introduction of supportive care every 6 weeks. | Other: Supportive care visit with questionnaires<br>* 5 Questionnaires (SCNS, QLQ-C30, HADS, PTPQ, GSE) will be filled by the patient with introduction of supportive care visit<br>Other: Oncological standard visit<br>* Oncological standard visit<br>|
| Active Comparator: Control group<br>Oncological standard of care at M0, M3, M6, M9 and M12. | Other: Oncological standard visit<br>* Oncological standard visit<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 34 items - Supportive Care Needs Survey | 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. | 6 months |