Uveal MelanomaEARLY TOGETHERNCT04728113
Early Integration of Supportive Care for Metastatic Uveal Melanoma Patients (EarlyTogether)
A study testing Supportive care visit with questionnaires and Oncological standard visit in people with Uveal Melanoma, run by Institut Curie at 2 sites in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Supportive care visit with questionnaires and Oncological standard visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Jul 2020to 22 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with metastatic UM;
- no surgery or loco-regional treatment of metastases in a curative intent;
- systemic treatment planned or started since less than 2 months;
- ECOG PS 0-1;
- no uncontrolled symptoms;
- liver function tests in normal range or ≤ grade 2;
- signed informed consent;
- able to fill the questionnaires.
Who cannot join
- patient<18 years old;
- patient condition requiring supportive care before any systemic specific treatment for metastases;
- acute psychopathological disorder incompatible with the study;
- prior medical condition incompatible with the study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Early Integration of Supportive Care Into Standard Oncology Care for Metastatic Uveal Melanoma Patients
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)
Read the 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.
- Conditions
- Uveal Melanoma
- Being tested
- Supportive care visit with questionnaires, Oncological standard visit
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive care visit with questionnairesOther
5 Questionnaires (SCNS, QLQ-C30, HADS, PTPQ, GSE) will be filled by the patient with introduction of supportive care visit
Oncological standard visitOther
Oncological standard visit
| Study group | Role | What they receive |
|---|---|---|
| Early together group | Experimental | Oncological standard of care at M0, M3, M6, M9 and M12 with early introduction of supportive care every 6 weeks. Receives: Other: Supportive care visit with questionnaires; Other: Oncological standard visit |
| Control group | Active comparator | Oncological standard of care at M0, M3, M6, M9 and M12. Receives: Other: Oncological standard visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
34 items - Supportive Care Needs Survey
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start16 Jul 2020
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PIPERNO NEUMAN Sophie, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728113
- Sponsor's protocol ID
- IC 2019-09
- Acronym
- EARLY TOGETHER
- Status last verified
- Feb 2025
- First submitted
- 8 Jan 2021
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Integration of Supportive Care Into Standard Oncology Care for Metastatic Uveal Melanoma Patients
- ClinicalTrials.gov ID
- NCT04728113
- Acronym / sponsor ID
- EARLY TOGETHER / IC 2019-09
- Conditions
- Uveal Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early together group | Experimental | Other: Supportive care visit with questionnaires, Other: Oncological standard visitOncological standard of care at M0, M3, M6, M9 and M12 with early introduction of supportive care every 6 weeks. |
| Control group | Active comparator | Other: Oncological standard visitOncological standard of care at M0, M3, M6, M9 and M12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- adult patients with metastatic UM;
- no surgery or loco-regional treatment of metastases in a curative intent;
- systemic treatment planned or started since less than 2 months;
- ECOG PS 0-1;
- no uncontrolled symptoms;
Key exclusion criteria (4 listed)
- patient<18 years old;
- patient condition requiring supportive care before any systemic specific treatment for metastases;
- acute psychopathological disorder incompatible with the study;
- prior medical condition incompatible with the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive care visit with questionnaires5 Questionnaires (SCNS, QLQ-C30, HADS, PTPQ, GSE) will be filled by the patient with introduction of supportive care visit | Other | Early together group |
| Oncological standard visitOncological standard visit | Other | Control group, Early together group |
Primary outcome
34 items - Supportive Care Needs Survey
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PIPERNO NEUMAN Sophie, MD principal investigator
Institut Curie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive care visit with questionnaires and Oncological standard visit in people with Uveal Melanoma, run by Institut Curie at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
34 items - Supportive Care Needs Survey (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.