Clinical trial · Interventional
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
NCT04728113CI-TRIAL-00094713EARLY TOGETHERcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncological standard visit | Other | — | UNRESOLVED |
| Supportive care visit with questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early together group
- description
- Oncological standard of care at M0, M3, M6, M9 and M12 with early introduction of supportive care every 6 weeks.
- interventionNames
- Other: Supportive care visit with questionnaires
- Other: Oncological standard visit
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Oncological standard of care at M0, M3, M6, M9 and M12.
- interventionNames
- Other: Oncological standard visit
Primary outcomes (1)
- measure
- 34 items - Supportive Care Needs Survey
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.