Bronchial CancerCombHADomNCT04802902
Feasibility of Immunotherapy Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting
An observational study of Bronchial Cancer, run by Centre Hospitalier de PAU 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-chemotherapy combo for bronchial cancer in maintenance phase of first row metastatic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Cancer
- What is being tested?
- home-based hospitalization
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2021to 8 Feb 2024
- 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 and chemotherapy combo in maintenance phase for bronchial cancer
Who may be able to join
- Patients aged 18 and over,
- with bronchial metastatic cancer treated in first row maintenance phase by immunotherapy-chemotherapy combo,
- having at least one 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
- 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 Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - CombHADom
This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy-chemotherapy combo for bronchial cancer in maintenance phase of first row metastatic treatment.
The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated. A cost-benefit analysis will be done to compare hospital-at-home programme and classical day hospitalization.
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. This type of management has particularly developed in the context of the COVID pandemic and recommendations for good practices in hospital-at-home immunotherapy have recently been drafted by FITC (Société Française d'Immuno-Thérapie du Cancer). These recommendations open the way for administration of immunotherapy and chemotherapy combo in hospital-at-home. At the moment, there is no study stating the feasibility of home hospitalization for patients treated by immunotherapy-chemotherapy combo. To follow up on the feasibility study of home immunotherapy (ImHADom) carried out at CH Pau from March 2019 to March 2021, the sponsor propose to evaluate with descriptive study the feasibility under the same conditions of chemotherapy-immunotherapy in patients treated in the maintenance phase of a first metastatic row.
This study will be proposed to all the patients in maintenance phase of first row treatment with at least one positive tumoral imaging assessment (stable disease or partial response) 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
- Being tested
- home-based hospitalization
- Keywords
- immunotherapy, chimiotherapy, Bronchial cancer, home-based hospitalization
- Medical subject headings
- Carcinoma, Bronchogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based hospitalizationOther
management in a hospital-at-home programme of patients treated by immunotherapy and chimiotherapy combo for bronchial cancer
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 (6)
Cost-benefit analysis
A cost-benefit analysis comparing hospital-at-home programme and classical day hospitalization
Measured: 1 year
Number of adverse effects occuring during the study
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: at month 3, 6 9 and 12
Healthcare professional satisfaction
Healthcare professional satisfaction will be assessed with a questionnaire. It will be collected at month 6, 12, 18 and 24 of the study
Measured: at month 6, 12, 18 and 24 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start29 Sep 2021
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
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
- Centre Hospitalier de PAU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802902
- Sponsor's protocol ID
- CHPAU2021/03
- Acronym
- CombHADom
- Status last verified
- Feb 2024
- First submitted
- 15 Mar 2021
- Last updated
- 26 Feb 2024
- 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 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Immunotherapy Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - CombHADom
- ClinicalTrials.gov ID
- NCT04802902
- Acronym / sponsor ID
- CombHADom / CHPAU2021/03
- Conditions
- Bronchial Cancer
- Keywords
- immunotherapy, chimiotherapy, Bronchial cancer, home-based hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier de PAUUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 17 Mar 2021 (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-chemotherapy combo for bronchial cancer in maintenance phase of first row metastatic treatment.
The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated. A cost-benefit analysis will be done to compare hospital-at-home programme and classical day hospitalization.
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. This type of management has particularly developed in the context of the COVID pandemic and recommendations for good practices in hospital-at-home immunotherapy have recently been drafted by FITC (Société Française d'Immuno-Thérapie du Cancer). These recommendations open the way for administration of immunotherapy and chemotherapy combo in hospital-at-home. At the moment, there is no study stating the feasibility of home hospitalization for patients treated by immunotherapy-chemotherapy combo. To follow up on the feasibility study of home immunotherapy (ImHADom) carried out at CH Pau from March 2019 to March 2021, the sponsor propose to evaluate with descriptive study the feasibility under the same conditions of chemotherapy-immunotherapy in patients treated in the maintenance phase of a first metastatic row.
This study will be proposed to all the patients in maintenance phase of first row treatment with at least one positive tumoral imaging assessment (stable disease or partial response) 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 and chemotherapy combo in maintenance phase for bronchial cancer
Key inclusion criteria (5 listed)
- Patients aged 18 and over,
- with bronchial metastatic cancer treated in first row maintenance phase by immunotherapy-chemotherapy combo,
- having at least one 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 (1 listed)
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home-based hospitalizationmanagement in a hospital-at-home programme of patients treated by immunotherapy and chimiotherapy combo for bronchial cancer | Other | – |
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.
6 secondary outcomes
Cost-benefit analysis
Time frame: 1 year
Number of adverse effects occuring during the study
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: at month 3, 6 9 and 12
Healthcare professional satisfaction
Time frame: at month 6, 12, 18 and 24 of the study
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 26 Feb 2024.
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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 Centre Hospitalier de PAU 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 1 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 26 Feb 2024. 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 26 Feb 2024.