CancerNCT06163053
A Study to Evaluate Satisfaction With Care in Patients With Cancer Receiving Immunotherapy Treatment at Home
An observational study of Cancer and Solid Tumors, run by Bristol-Myers Squibb at 3 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumors
- What is being tested?
- Immunotherapy
- How many people
- 49 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Aug 2023to 12 Jun 2025
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in France with solid tumors transitioning from receiving immunotherapy treatment in the hospital outpatient setting to receiving treatment at home
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
CH Metropole Savoie
Chambéry, 73011
CH Francois Quesnay
Mantes-la-Jolie, 78200
CH de Pau
Pau, 64046
About this study
Official title: A French Non-interventional Prospective Multicenter Study Evaluating Quality of Care Perception of Cancer Patients Treated by Immunotherapy at Home - SATISFACT-HOME
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
- Being tested
- Immunotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyDrug
Immune checkpoint inhibitors in approved indications
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving immunotherapy at home | Not described Receives: Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Participants follow up approximately 24 weeks after transition to treatment at home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start29 Aug 2023
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163053
- Sponsor's protocol ID
- CA209-6JE
- Status last verified
- Jan 2026
- First submitted
- 30 Nov 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A French Non-interventional Prospective Multicenter Study Evaluating Quality of Care Perception of Cancer Patients Treated by Immunotherapy at Home - SATISFACT-HOME
- ClinicalTrials.gov ID
- NCT06163053
- Acronym / sponsor ID
- CA209-6JE
- Conditions
- Cancer, Solid Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving immunotherapy at home | – | Drug: Immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in France with solid tumors transitioning from receiving immunotherapy treatment in the hospital outpatient setting to receiving treatment at home
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunotherapyImmune checkpoint inhibitors in approved indications | Drug | Participants receiving immunotherapy at home |
Primary outcome
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
Time frame: Participants follow up approximately 24 weeks after transition to treatment at home
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Solid Tumors, run by Bristol-Myers Squibb at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Participants follow up approximately 24 weeks after transition to treatment at home). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.