Clinical trial NCT03786653: Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting (ImHADom)
Official title: Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - ImHADom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Cancer
Keywords: Immunotherapy, bronchial cancer, home-based hospitalization
Lead sponsor: Centre Hospitalier de PAU
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated by immunotherapy for bronchial cancer

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.

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

Primary outcomes:
measure: Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management)
timeFrame: 1 year
Secondary outcomes:
measure: adverse effects
timeFrame: 1 year
measure: Number of Incidents occurring during the Hospital at Home program handling process
timeFrame: 1 year
measure: Quality of Life Questionnaire (EORTC QLQ-C30) total score
timeFrame: at inclusion, month 3, 6 9 and 12
measure: Patients' Satisfaction Questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Pau
country: France
facility: Centre hospitalier de pau
state: Aquitaine
Study officials:
References: