Bronchial CancerImHADomNCT03786653
Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting (ImHADom)
An observational study of Bronchial Cancer, run by RENAULT Patrick Aldo at 1 site in France.
Trial summary
This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy for bronchial cancer. The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Cancer
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2019to 6 Dec 2020
- 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: Patients treated by immunotherapy for bronchial cancer
Who may be able to join
- Patients aged 18 and over.
- with bronchial cancer treated with immunotherapy,
- having two assessments of the response to immunotherapy received in day hospitalization with efficiency (stability or partial response)
- without any graded higher than 1 adverse effects, or uncontrolled grade 1 adverse effects related to immunotherapy
- eligible for a home-based hospitalization
Who cannot join
- Patient receiving immunotherapy via temporary authorization for use,
- Frail patients requiring a frequent medical assessment thus day hospitalization cares
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - ImHADom
This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy for bronchial cancer.
The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated.
Read the detailed description
Those last years, immunotherapy treatment for bronchial cancers allowed considerable progress in terms of tumoral answer, survival without progression and global survival. Usually administered in the day hospitalization department, its preparation and administration to the patient are compatible with hospital-at-home management. Currently, this offer of care is rarely proposed, and only in particular situations. At the Hospital of Pau, it was introduced recently. It is proposed to patients who have been receiving immunotherapy for at least 4 months. At the moment, there is no study stating the feasibility of home hospitalization for patients treated by immunotherapy. Given that there is neither regulatory obstacle nor any contraindication to care in home hospitalization, the choice of a descriptive study stands out.
This study will be proposed to all the patients for whom home hospitalization has been decided and scheduled by the healthcare team in a medical staff meeting.
The patients included in the study will be followed according to the common practice: a consultation every 3 months during 1 year.
- Conditions
- Bronchial Cancer
- Keywords
- Immunotherapy, bronchial cancer, home-based hospitalization
- Medical subject headings
- Carcinoma, Bronchogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management)
Feasibility under good conditions of home-based immunotherapy, defined by the percentage of patients who interrupted their home hospitalization for reasons directly linked to that management.
Measured: 1 year
Secondary outcomes (4)
adverse effects
Immunotherapy related adverse effects monitoring criteria evaluation
Measured: 1 year
Number of Incidents occurring during the Hospital at Home program handling process
The occurrence of possible incidents related to the Hospital at Home program will be collected at each home based hospitalization.
Measured: 1 year
Quality of Life Questionnaire (EORTC QLQ-C30) total score
To study the patient's reported quality of life before and throughout therapy. Quality of life score obtained through self-administered EORCT QLQ-C30 questionnaire at inclusion, month 3, 6 9 and 12.
Measured: at inclusion, month 3, 6 9 and 12
Patients' Satisfaction Questionnaire
Patients' satisfaction with their home base management will be assessed with a questionnaire. It will be collected at month 3, 6 9 and 12.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start6 Mar 2019
- Primary completion6 Dec 2020
- Study completion6 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- RENAULT Patrick Aldo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, RENAULT Patrick Aldo, Centre Hospitalier de PAU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786653
- Sponsor's protocol ID
- CHPAU2018/02
- Acronym
- ImHADom
- Status last verified
- Jan 2021
- First submitted
- 19 Dec 2018
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - ImHADom
- ClinicalTrials.gov ID
- NCT03786653
- Acronym / sponsor ID
- ImHADom / CHPAU2018/02
- Conditions
- Bronchial Cancer
- Keywords
- Immunotherapy, bronchial cancer, home-based hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- RENAULT Patrick AldoUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 6 Dec 2020 (actual)
- First posted
- 26 Dec 2018 (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.
This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy for bronchial cancer.
The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated.
Detailed description
Those last years, immunotherapy treatment for bronchial cancers allowed considerable progress in terms of tumoral answer, survival without progression and global survival. Usually administered in the day hospitalization department, its preparation and administration to the patient are compatible with hospital-at-home management. Currently, this offer of care is rarely proposed, and only in particular situations. At the Hospital of Pau, it was introduced recently. It is proposed to patients who have been receiving immunotherapy for at least 4 months. At the moment, there is no study stating the feasibility of home hospitalization for patients treated by immunotherapy. Given that there is neither regulatory obstacle nor any contraindication to care in home hospitalization, the choice of a descriptive study stands out.
This study will be proposed to all the patients for whom home hospitalization has been decided and scheduled by the healthcare team in a medical staff meeting.
The patients included in the study will be followed according to the common practice: a consultation every 3 months during 1 year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by immunotherapy for bronchial cancer
Key inclusion criteria (5 listed)
- Patients aged 18 and over.
- with bronchial cancer treated with immunotherapy,
- having two assessments of the response to immunotherapy received in day hospitalization with efficiency (stability or partial response)
- without any graded higher than 1 adverse effects, or uncontrolled grade 1 adverse effects related to immunotherapy
- eligible for a home-based hospitalization
Key exclusion criteria (2 listed)
- Patient receiving immunotherapy via temporary authorization for use,
- Frail patients requiring a frequent medical assessment thus day hospitalization cares
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management)
Time frame: 1 year
Feasibility under good conditions of home-based immunotherapy, defined by the percentage of patients who interrupted their home hospitalization for reasons directly linked to that management.
4 secondary outcomes
adverse effects
Time frame: 1 year
Number of Incidents occurring during the Hospital at Home program handling process
Time frame: 1 year
Quality of Life Questionnaire (EORTC QLQ-C30) total score
Time frame: at inclusion, month 3, 6 9 and 12
Patients' Satisfaction Questionnaire
Time frame: 1 year
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 11 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Cancer, run by RENAULT Patrick Aldo at 1 site 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 5 inclusion and 2 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management) (time frame: 1 year). 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 11 Sep 2025.