Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting (ImHADom) (ImHADom)
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|ClinicalTrials.gov Identifier: NCT03786653|
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : March 8, 2019
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - ImHADom|
|Actual Study Start Date :||March 6, 2019|
|Estimated Primary Completion Date :||March 5, 2021|
|Estimated Study Completion Date :||March 5, 2021|
- 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.
- adverse effects [ Time Frame: 1 year ]Immunotherapy related adverse effects monitoring criteria evaluation
- 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.
- 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.
- Patients' Satisfaction Questionnaire [ Time Frame: 1 year ]Patients' satisfaction with their home base management will be assessed with a questionnaire. It will be collected at month 3, 6 9 and 12.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786653
|Contact: Alice Séris||05 59 72 69 email@example.com|
|Centre hospitalier de pau||Recruiting|
|Pau, Aquitaine, France, 64160|
|Contact: Patrick Aldo PI RENAULT 0559924723 firstname.lastname@example.org|