A Study to Evaluate Satisfaction With Care in Patients With Cancer Receiving Immunotherapy Treatment at Home

Recruiting

• Conditions: Cancer; Solid Tumors
• Interventions: Drug: Immunotherapy

• Registration Number: NCT06163053
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-29
• Status Verified: 2023-11
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Study First Posted: 2023-12-08
• Last Update Posted: 2023-12-08
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants receiving immunotherapy at home	Immunotherapy	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

CH Francois Quesnay; 🇫🇷 Mantes-La-Jolie, France

CH de Pau; 🇫🇷 Pau, France

CH Metropole Savoie; 🇫🇷 Chambéry, France