Feasibility of Immunotherapy Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting
CombHADom
1 other identifier
observational
10
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedStudy Start
First participant enrolled
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2024
CompletedFebruary 26, 2024
February 1, 2024
2.4 years
March 15, 2021
February 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (6)
Cost-benefit analysis
1 year
Number of adverse effects occuring during the study
1 year
Number of Incidents occurring during the Hospital at Home program handling process
1 year
Quality of Life Questionnaire (EORTC QLQ-C30) total score
at inclusion, month 3, 6 9 and 12
Patients' Satisfaction Questionnaire
at month 3, 6 9 and 12
- +1 more secondary outcomes
Interventions
management in a hospital-at-home programme of patients treated by immunotherapy and chimiotherapy combo for bronchial cancer
Eligibility Criteria
Patients treated by immunotherapy and chemotherapy combo in maintenance phase for bronchial cancer
You may qualify if:
- 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
You may not qualify if:
- Frail patients requiring a frequent medical assessment thus day hospitalization cares
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre hospitalier de pau
Pau, Aquitaine, 64160, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2021
First Posted
March 17, 2021
Study Start
September 29, 2021
Primary Completion
February 8, 2024
Study Completion
February 8, 2024
Last Updated
February 26, 2024
Record last verified: 2024-02