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

Centre Hospitalier de PAU

Status: Completed

Conditions: Bronchial Cancer

Treatments: Other: home-based hospitalization

Study type: Observational

Funder types: Other

Identifiers

NCT04802902

CHPAU2021/03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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