Clinical trial

A French Non-interventional Prospective Multicenter Study Evaluating Quality of Care Perception of Cancer Patients Treated by Immunotherapy at Home - SATISFACT-HOME

Name

CA209-6JE

Description

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

Trial arms

Trial start

2023-08-29

Estimated PCD

2025-02-28

Trial end

2025-02-28

Status

Recruiting

Treatment

Immunotherapy

Immune checkpoint inhibitors in approved indications

Arms:

Participants receiving immunotherapy at home

Size

150

Primary endpoint

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

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '24 Weeks', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

Updated at

2023-12-08

1 organization

1 product

2 indications

Organization

Product

Indication

Indication