Status:
COMPLETED
Feasiblity and Safety of Home-based Intensive Chemotherapy
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Acute Leukemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
a multicenter single-arm feasibility and safety study of home-based intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia and their quality of life and psychological wellbeing...
Detailed Description
This national single-arm feasibility cohort study was conducted at six hematology departments at six university hospitals in Denmark: Copenhagen University Hospital, Rigshospitalet; Herlev/Gentofte Ho...
Eligibility Criteria
Inclusion
- Participants 18 years or older were included within the first 28 days from diagnosis with AML or high-risk MDS if intensive chemotherapy treatment was planned.
Exclusion
- Patients were excluded if they did not understand, read and speak Danish, suffered from a severe illness requiring hospitalization if they had an unstable medical disease or any cognitive/psychiatric disorders. During the intervention, participants were withdrawn if hospitalized in an intensive care unit for more than two weeks, if they had a psychological condition (delirium or severe depression), or in case of transition to terminal care or if deceased. Moreover, participants were censored if they relapsed or transitioned to hematopoietic stem cell transplantation (HSCT).
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04904211
Start Date
January 1 2017
End Date
September 1 2020
Last Update
May 27 2021
Active Locations (6)
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1
Aalborg University Hospital
Aalborg, Denmark
2
Aarhus University Hospital
Aarhus, Denmark
3
Herlev Hospital
Herlev, Denmark, 2730
4
Odense University Hospital
Odense, Denmark