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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Uveal Melanoma
• Intervention / Treatment: Other: Supportive care visit with questionnaires; Other: Oncological standard visit

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.

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Emmanuelle LEGRIER; Phone Number: 33 156245649; Email: marieemmanuelle.legrier@curie.fr

Study Locations

• France
  • Nice, France, 06189
    • Recruiting
    • Centre Antoine Lacassagne
    • Contact: Agnès DUCOULOMBIER, MD
    • Principal Investigator: Agnès DUCOULOMBIER, MD
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
    • Contact: Sophie PIPERNO NEUMANN, MD
    • Principal Investigator: Sophie PIPERNO NEUMANN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: PIPERNO NEUMAN Sophie, MD, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2020
• Primary Completion (Estimated): January 19, 2025
• Study Completion (Estimated): July 20, 2025

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Eye Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Uveal Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Eye Neoplasms; Melanoma; Uveal Neoplasms
• Other Study ID Numbers: IC 2019-09 EARLY TOGETHER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No