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

  • STATUS
    Recruiting
  • End date
    Jul 16, 2025
  • participants needed
    162
  • sponsor
    Institut Curie
Updated on 2 February 2021

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)

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.

Details
Condition Uveal Melanoma
Treatment Supportive care visit with questionnaires, Oncological standard visit
Clinical Study IdentifierNCT04728113
SponsorInstitut Curie
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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