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 Information
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
Administrative Informations
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