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

Completed

• Conditions: Bronchial Cancer

• Registration Number: NCT03786653
• Lead Sponsor: RENAULT Patrick Aldo

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 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 Timeline

• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-24
• Study First Posted: 2018-12-26
• Study Start: 2019-03-06
• Primary Completion: 2020-12-06
• Study Completion: 2020-12-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

• Patient receiving immunotherapy via temporary authorization for use,
• Frail patients requiring a frequent medical assessment thus day hospitalization cares

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management)	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.

Secondary Outcome Measures

Name	Time	Method
adverse effects	1 year	Immunotherapy related adverse effects monitoring criteria evaluation
Number of Incidents occurring during the Hospital at Home program handling process	1 year	The occurrence of possible incidents related to the Hospital at Home program will be collected at each home based hospitalization.
Quality of Life Questionnaire (EORTC QLQ-C30) total score	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.
Patients' Satisfaction Questionnaire	1 year	Patients' satisfaction with their home base management will be assessed with a questionnaire. It will be collected at month 3, 6 9 and 12.

Trial Locations

Locations (1)

Centre hospitalier de pau; 🇫🇷 Pau, Aquitaine, France