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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06163053
Other study ID # CA209-6JE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 29, 2023
Est. completion date February 28, 2025

Study information

Verified date November 2023
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this observational study in France is to evaluate changes in satisfaction with care in participants with solid tumors who transitioned from receiving immunotherapy treatment in the hospital outpatient setting to receiving treatment at home


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female = 18 years old - Participants whose oncology specialist has already initiated treatment with immune checkpoint inhibitors (ICIs) in the outpatient hospital setting for an advanced solid tumor (as monotherapy or in combination) or as adjuvant therapy, in an indication approved and reimbursed in France - Participants whose oncology specialist has independently of the study defined their eligibility for hospital at home (HAH) before contacting the HAH unit for final admission - Participants who provide oral informed consent to participate in the study Exclusion Criteria: - Participants who have expressed an opposition to their data collection - Participants under guardianship - Participants taking part in an interventional study for cancer treatment with at least one ICI as an investigational drug

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Immunotherapy
Immune checkpoint inhibitors in approved indications

Locations

Country Name City State
France CH Metropole Savoie Chambéry
France CH Francois Quesnay Mantes-La-Jolie
France CH de Pau Pau

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in patient satisfaction on the European Organisation for Research and Treatment of Cancer satisfaction with cancer care core questionnaire (EORTC PATSAT-C33) when transitioning from Outpatient Hospital to Hospital at Home to receive immunotherapy Participants follow up approximately 24 weeks after transition to treatment at home
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