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OpenTrials
Completed

NCT Number: NCT04728113

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

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)

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Antoine Lacassagne, Nice, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supportive care visit with questionnaires

Other

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

Oncological standard visit

Other

Oncological standard visit

Primary outcomes

  1. 34 items - Supportive Care Needs Survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Acronym: EARLY TOGETHER

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2021
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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