NCT04728113

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2025

Completed
Last Updated

September 8, 2025

Status Verified

February 1, 2025

Enrollment Period

4.5 years

First QC Date

January 8, 2021

Last Update Submit

September 2, 2025

Conditions

Uveal Melanoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Early together group

EXPERIMENTAL

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 questionnairesOther: Oncological standard visit

Control group

ACTIVE COMPARATOR

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

Other: Oncological standard visit

Interventions

Supportive care visit with questionnairesOTHER

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

Early together group
Oncological standard visitOTHER

Oncological standard visit

Control groupEarly together group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • PIPERNO NEUMAN Sophie, MD

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 28, 2021

Study Start

July 16, 2020

Primary Completion

January 22, 2025

Study Completion

January 22, 2025

Last Updated

September 8, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access Criteria
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR(2)