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NCT Number: NCT04802902

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

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.

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Key information

Conditions

Bronchial Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier de pau

Pau, Aquitaine, 64160, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

home-based hospitalization

Other

management in a hospital-at-home programme of patients treated by immunotherapy and chimiotherapy combo for bronchial cancer

Primary outcomes

  1. Feasibility of home-based immunotherapy (percentage of patients who interrupted their home hospitalization for reasons directly linked to that management)

    Time frame: 1 year

    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.

Secondary outcomes

  1. Cost-benefit analysis

    Time frame: 1 year

    A cost-benefit analysis comparing hospital-at-home programme and classical day hospitalization

  2. Number of adverse effects occuring during the study

    Time frame: 1 year

    Immunotherapy related adverse effects monitoring criteria evaluation

  3. Number of Incidents occurring during the Hospital at Home program handling process

    Time frame: 1 year

    The occurrence of possible incidents related to the Hospital at Home program will be collected at each home based hospitalization.

  4. Quality of Life Questionnaire (EORTC QLQ-C30) total score

    Time frame: at inclusion, month 3, 6 9 and 12

    To study the patient's reported quality of life before and throughout therapy. Quality of life score obtained through self-administered EORCT QLQ-C30 questionnaire at inclusion, month 3, 6 9 and 12.

  5. Patients' Satisfaction Questionnaire

    Time frame: at month 3, 6 9 and 12

    Patients' satisfaction with their home base management will be assessed with a questionnaire. It will be collected at month 3, 6 9 and 12

  6. Healthcare professional satisfaction

    Time frame: at month 6, 12, 18 and 24 of the study

    Healthcare professional satisfaction will be assessed with a questionnaire. It will be collected at month 6, 12, 18 and 24 of the study

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de PAU

Other

Registry information

Official study title

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

Acronym: CombHADom

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2021
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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