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

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchial Cancer

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated by immunotherapy for bronchial cancer

Description

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 Plan

How is the study designed?

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)	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
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
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
adverse effects	Immunotherapy related adverse effects monitoring criteria evaluation	1 year
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

Collaborators and Investigators

• Sponsor: RENAULT Patrick Aldo

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2019
• Primary Completion (ACTUAL): December 6, 2020
• Study Completion (ACTUAL): December 6, 2020

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 24, 2018
• First Posted (ACTUAL): December 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Immunotherapy, bronchial cancer, home-based hospitalization
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic
• Other Study ID Numbers: CHPAU2018/02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No