Feasibility of Immunotherapy Administration to Patients W... | NCT03786653

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

NCT03786653

Sponsor

RENAULT Patrick Aldo

Status

Completed

Last Update Posted

Sep 11, 2025Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Bronchial Cancer

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2019Actual

Primary Completion Date

Dec 6, 2020Actual

Completion Date

Dec 6, 2020Actual

First Submitted Date

Dec 19, 2018

First Submission Date that Met QC Criteria

Dec 24, 2018

First Posted Date

Dec 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2025

Last Update Posted Date

Sep 11, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

RENAULT Patrick Aldo, Principal Investigator, Centre Hospitalier de PAUSponsor-Investigator

Lead Sponsor

RENAULT Patrick AldoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
adverse effects	Immunotherapy related adverse effects monitoring criteria evaluation	1 year
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients treated by immunotherapy for bronchial cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier de pau		Pau	Aquitaine	64160	France

Condition Browse Module

MeSH Terms

ID	Term
D002283	Carcinoma, Bronchogenic

Ancestor Terms

ID	Term
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided