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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04728113
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut Curie
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	PIPERNO NEUMAN Sophie, MD
Principal Investigator Affiliation	Institut Curie
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Uveal Melanoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Early together group

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

Active Comparator: Control group

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Antoine Lacassagne, Nice, France

Status

Recruiting

Address

Centre Antoine Lacassagne

Nice, , 06189

Site Contact

Agnès DUCOULOMBIER, MD

[email protected]

156245649

Institut Curie, Paris, France

Status

Recruiting

Address

Institut Curie

Paris, , 75005

Site Contact

Sophie PIPERNO NEUMANN, MD

[email protected]

156245649

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