A Study to Evaluate Satisfaction With Care in Patients Wi... | NCT06163053

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

NCT06163053

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jan 14, 2026Actual

Enrollment

49Actual

Phase

Not provided

Conditions

Cancer
Solid Tumors

Interventions

Immunotherapy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 29, 2023Actual

Primary Completion Date

Jun 12, 2025Actual

Completion Date

Jun 12, 2025Actual

First Submitted Date

Nov 30, 2023

First Submission Date that Met QC Criteria

Nov 30, 2023

First Posted Date

Dec 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2026

Last Update Posted Date

Jan 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

24 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants receiving immunotherapy at home			Drug: Immunotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunotherapy	Drug	Immune checkpoint inhibitors in approved indications	Participants receiving immunotherapy at home

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CH Metropole Savoie		Chambéry		73011	France
CH Francois Quesnay

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
Investigator Inquiry Form	View source
FDA Safety Alerts and Recalls

ID	Term
D056747	Immunomodulation
D001691	Biological Therapy
D013812	Therapeutics