Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Eye Diseases

Rare Diseases

Melanoma

Uveal Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Eye Neoplasms

Uveal Diseases

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

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

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

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

Supportive care visit with questionnaires

Oncological standard visit

Marie-Emmanuelle LEGRIER

Agnès DUCOULOMBIER, MD

Sophie PIPERNO NEUMANN, MD

PIPERNO NEUMAN Sophie, MD

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)

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.

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

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

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.

Institut Curie

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Early Integration of Supportive Care for Metastatic Uveal Melanoma Patients (EarlyTogether)	NCT04728113	Uveal Melanoma	Supportive care... Oncological sta...	18 Years -	Institut Curie
Early Integration of Supportive Care for Metastatic Uveal Melanoma Patients (EarlyTogether)	NCT04728113	Uveal Melanoma	Supportive care... Oncological sta...	18 Years -	Institut Curie

Spots Global Cancer Trial Database for supportive care visit with questionnaires