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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
Sponsor:
Information provided by (Responsible Party):
RENAULT Patrick Aldo, Centre Hospitalier de PAU

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.


Condition or disease
Bronchial Cancer

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.


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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  1. adverse effects [ Time Frame: 1 year ]
    Immunotherapy related adverse effects monitoring criteria evaluation

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated by immunotherapy for bronchial cancer
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

Information from the National Library of Medicine

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


Contacts
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Contact: Alice Séris 05 59 72 69 97 alice.seris@ch-pau.fr

Locations
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France
Centre hospitalier de pau Recruiting
Pau, Aquitaine, France, 64160
Contact: Patrick Aldo PI RENAULT    0559924723    aldo.renault@ch-pau.fr   
Sponsors and Collaborators
RENAULT Patrick Aldo

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Responsible Party: RENAULT Patrick Aldo, Principal Investigator, Centre Hospitalier de PAU
ClinicalTrials.gov Identifier: NCT03786653     History of Changes
Other Study ID Numbers: CHPAU2018/02
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RENAULT Patrick Aldo, Centre Hospitalier de PAU:
Immunotherapy, bronchial cancer, home-based hospitalization

Additional relevant MeSH terms:
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Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs