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

Sponsor

Institut Curie (Other)

Overall Status

Recruiting

CT.gov ID

NCT04728113

Collaborator

(none)

162

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Uveal Melanoma	Other: Supportive care visit with questionnaires Other: Oncological standard visit	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 16, 2020

Anticipated Primary Completion Date :

Jul 16, 2024

Anticipated Study Completion Date :

Jul 16, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early together group Oncological standard of care at M0, M3, M6, M9 and M12 with early introduction of supportive care every 6 weeks.	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
Active Comparator: Control group Oncological standard of care at M0, M3, M6, M9 and M12.	Other: Oncological standard visit Oncological standard visit

Arm

Intervention/Treatment

Experimental: Early together group

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

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

Active Comparator: Control group

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

Other: Oncological standard visit

Oncological standard visit

Outcome Measures

Primary Outcome Measures

34 items - Supportive Care Needs Survey [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Antoine Lacassagne	Nice		France	06189
2	Institut Curie	Paris		France	75005

Sponsors and Collaborators

Institut Curie

Investigators

Principal Investigator: PIPERNO NEUMAN Sophie, MD, Institut Curie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Curie

ClinicalTrials.gov Identifier:

NCT04728113

Other Study ID Numbers:

IC 2019-09 EARLY TOGETHER

First Posted:

Jan 28, 2021

Last Update Posted:

Feb 1, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Melanoma

Uveal Neoplasms

Study Results

No Results Posted as of Feb 1, 2021