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

Brief Title

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

Official Title

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

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.
    

Study Type

Interventional

Primary Outcome

34 items - Supportive Care Needs Survey

Condition

Uveal Melanoma

Intervention

Supportive care visit with questionnaires

Study Arms / Comparison Groups

 Early together group

Description:  Oncological standard of care at M0, M3, M6, M9 and M12 with early introduction of supportive care every 6 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

162

Start Date

July 16, 2020

Completion Date

July 16, 2026

Primary Completion Date

July 16, 2025

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

PIPERNO NEUMAN Sophie, MD, 1 47 11 16 54, [email protected]

Location Countries

France

Location Countries

France

NCT ID

NCT04728113

Organization ID

IC 2019-09 EARLY TOGETHER

Responsible Party

Sponsor

Study Sponsor

Institut Curie

Study Sponsor

PIPERNO NEUMAN Sophie, MD, Principal Investigator, Institut Curie

Verification Date

January 2023