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

Uveal Melanoma Clinical Trial

Official title:

Early Integration of Supportive Care Into Standard Oncology Care for Metastatic Uveal Melanoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04728113
• Other study ID #: IC 2019-09 EARLY TOGETHER
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2020
• Est. completion date: July 20, 2025

Study information

• Verified date: November 2023
• Source: Institut Curie
• Contact: Marie-Emmanuelle LEGRIER
• Phone: 156245649
• Email: marieemmanuelle.legrier[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: July 20, 2025
• Est. primary completion date: January 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Intervention

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
• Oncological standard visit
Oncological standard visit

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months