NCT03786653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

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

December 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 6, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2020

Completed
Last Updated

September 11, 2025

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

December 19, 2018

Last Update Submit

September 5, 2025

Conditions

Bronchial Cancer

Keywords

Immunotherapy, bronchial cancer, home-based hospitalization

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 (4)

  • adverse effects

    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

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated by immunotherapy for bronchial cancer

You may qualify if:

  • 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

You may not qualify if:

  • Patient receiving immunotherapy via temporary authorization for use,
  • 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

Location

MeSH Terms

Conditions

Carcinoma, Bronchogenic

Condition Hierarchy (Ancestors)

Bronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 26, 2018

Study Start

March 6, 2019

Primary Completion

December 6, 2020

Study Completion

December 6, 2020

Last Updated

September 11, 2025

Record last verified: 2021-01

Locations

FR(1)