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

NCT06163053 | Completed FDA Drug

• 1 other identifier: CA209-6JE
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 3

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

Conditions

Cancer; Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Participants receiving immunotherapy at home

Drug: Immunotherapy

Interventions

Immunotherapy DRUG

Immune checkpoint inhibitors in approved indications

Participants receiving immunotherapy at home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in France with solid tumors transitioning from receiving immunotherapy treatment in the hospital outpatient setting to receiving treatment at home

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

CH Metropole Savoie

Chambéry, 73011, France

Location

CH Francois Quesnay

Mantes-la-Jolie, 78200, France

Location

CH de Pau

Pau, 64046, France

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Neoplasms

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: August 29, 2023
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)