Clinical trial NCT04802902: Feasibility of Immunotherapy Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting
Official title: Feasibility of Immunotherapy Plus Chemotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - CombHADom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Cancer
Keywords: immunotherapy
chimiotherapy
Bronchial cancer
home-based hospitalization
Lead sponsor: Centre Hospitalier de PAU
Sponsor class: OTHER
First posted: 2021-03-17
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 and chemotherapy combo in maintenance phase 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-chemotherapy combo for bronchial cancer in maintenance phase of first row metastatic treatment.

The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated. A cost-benefit analysis will be done to compare hospital-at-home programme and classical day hospitalization.

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. This type of management has particularly developed in the context of the COVID pandemic and recommendations for good practices in hospital-at-home immunotherapy have recently been drafted by FITC (Société Française d'Immuno-Thérapie du Cancer). These recommendations open the way for administration of immunotherapy and chemotherapy combo in hospital-at-home. At the moment, there is no study stating the feasibility of home hospitalization for patients treated by immunotherapy-chemotherapy combo. To follow up on the feasibility study of home immunotherapy (ImHADom) carried out at CH Pau from March 2019 to March 2021, the sponsor propose to evaluate with descriptive study the feasibility under the same conditions of chemotherapy-immunotherapy in patients treated in the maintenance phase of a first metastatic row.

This study will be proposed to all the patients in maintenance phase of first row treatment with at least one positive tumoral imaging assessment (stable disease or partial response) 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 metastatic cancer treated in first row maintenance phase by immunotherapy-chemotherapy combo,
* having at least one 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:

* 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: Cost-benefit analysis
timeFrame: 1 year
measure: Number of adverse effects occuring during the study
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: at month 3, 6 9 and 12
measure: Healthcare professional satisfaction
timeFrame: at month 6, 12, 18 and 24 of the study
Other outcomes:
Locations:
city: Pau
country: France
facility: Centre hospitalier de pau
state: Aquitaine
Study officials:
References: