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

Bronchial Cancer Clinical Trial

— ImHADom  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03786653
• Other study ID #: CHPAU2018/02
• Status: Completed
• Start date: March 6, 2019
• Est. completion date: December 6, 2020

Study information

• Verified date: January 2021
• Source: Centre Hospitalier de PAU
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 6, 2020
• Est. primary completion date: December 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchial Cancer
• Carcinoma, Bronchogenic

Locations

Country	Name	City	State
France	Centre hospitalier de pau	Pau	Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
RENAULT Patrick Aldo

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	adverse effects	Immunotherapy related adverse effects monitoring criteria evaluation	1 year
Secondary	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.	1 year
Secondary	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.	at inclusion, month 3, 6 9 and 12
Secondary	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.	1 year