Follow-up of Oncology Patients After Hospitalization in ICU

NCT ID: NCT02398890

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 309 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-12-17

Brief Summary

"Purpose: The overall prognosis of oncology patients admitted to intensive care has improved greatly in recent years, leading to a wider admission policy. Due to a decrease in mortality in intensive care, more and more patients returning oncological circuit for the continuation of treatment of the underlying disease The existence of sequelae after the ICU (Intensive Care Unit) stay, whether renal, cardiac, respiratory or other, may influence the continuation of the optimal anti -cancer treatments and thus reduce the chances of recovery or evolution without tumor progression. However, no studies have evaluated the effects of resuscitation on subsequent cancer treatment strategies. It would thus become better appreciate the long-term oncology patients discharged alive from the hospital after a stay in intensive care.

Main purpose of research :

Assess the feasibility of a anti-tumor therapy for patients with progressive solid tumors, after an intensive care stay for other reason than elective surgery monitoring or securing an invasive procedure. The possibility of making an anti -cancer treatment will be evaluated by the treating oncologist and classified total, partial or absent from that defined before or during the ICU stay

Secondary objective of the research :

Evaluate the percentage of patients discharged alive from the ICU and dying in the hospital.

Evaluate survival, lifestyle and physical and psychological effects of these patients after discharge from the hospital over a period of one year. It is understood that all these secondary endpoints will interfere with the existence of an evolutionary neoplasia not only with the ICU stay. They will therefore be interpreted with caution.

Study Type: observational Study Design: Prognostic study of routine care, national, prospective, cohort type "

Detailed Description

"Nature of evaluated care: Longitudinal follow-up of post- resuscitation intensive care Concerned population: adult patients with active solid tumor out alive from the ICU and following-up in oncology in the same hospital as the resuscitator investigator.

Main objective: Measure the influence of ICU for patients with solid cancers to continue with optimal anti -cancer treatment, defined before or during hospitalization in intensive care.

Secondary objective: Assess the physical and psychological consequences of ICU stay of patients Evaluation criteria : Primary endpoint: proportion of patients living, out from ICU and hospital, can receive optimal cancer treatment later.

Research Methodology : Prognostic study of routine care, national, prospective, cohort type."

Conditions

Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

routine care

routine care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient with progressive solid tumor hospitalized in intensive care and got out alive
• Oncology patients followed in the same hospital as the investigator resuscitator
• Age ≥ 18 years
• Affiliate of social insurance
• Agree to participate

Exclusion Criteria

• Patient hospitalized for programed surgery
• Hospitalization for securing procedure
• Pregnancy or breastfeeding woman

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHI Le Raincy-Montfermeil

Montfermeil, , France

Countries

France

Other Identifiers

2013-A00683-42

Identifier Type: OTHER

Identifier Source: secondary_id

KI120906

Identifier Type: -

Identifier Source: org_study_id