Feasibility of Immunotherapy Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting (CombHADom)

February 23, 2024 updated by: Centre Hospitalier de PAU

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Aquitaine
      • Pau, Aquitaine, France, 64160
        • Centre Hospitalier de Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients treated by immunotherapy and chemotherapy combo in maintenance phase for bronchial cancer

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Frail patients requiring a frequent medical assessment thus day hospitalization cares

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-benefit analysis
Time Frame: 1 year
A cost-benefit analysis comparing hospital-at-home programme and classical day hospitalization
1 year
Number of adverse effects occuring during the study
Time Frame: 1 year
Immunotherapy related adverse effects monitoring criteria evaluation
1 year
Number of Incidents occurring during the Hospital at Home program handling process
Time Frame: 1 year
The occurrence of possible incidents related to the Hospital at Home program will be collected at each home based hospitalization.
1 year
Quality of Life Questionnaire (EORTC QLQ-C30) total score
Time Frame: at inclusion, month 3, 6 9 and 12
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.
at inclusion, month 3, 6 9 and 12
Patients' Satisfaction Questionnaire
Time Frame: at month 3, 6 9 and 12
Patients' satisfaction with their home base management will be assessed with a questionnaire. It will be collected at month 3, 6 9 and 12
at month 3, 6 9 and 12
Healthcare professional satisfaction
Time Frame: at month 6, 12, 18 and 24 of the study
Healthcare professional satisfaction will be assessed with a questionnaire. It will be collected at month 6, 12, 18 and 24 of the study
at month 6, 12, 18 and 24 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de PAU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2021

Primary Completion (Actual)

February 8, 2024

Study Completion (Actual)

February 8, 2024

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHPAU2021/03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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