Feasiblity and Safety of Home-based Intensive Chemotherapy
A National Danish Proof of Concept on Feasiblity and Safety of Home-based Intensive Chemotherapy in Patients With Acute Leukemia.
Study Overview
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 Hospital; Zealand University Hospital, Roskilde; Odense University Hospital; Aarhus University Hospital, and Aalborg University Hospital.
The project nurse at each site approached and recruited participants from October 2017 to August 2020. The participants were explicitly evaluated for their ability to manage their symptoms, administer oral medication, eat and drink sufficiently, and practice good personal hygiene. Eligible participants received oral and written information and provided written informed consent before inclusion.
Included participants received intensive chemotherapy treatment on a CADD pump through their CVC. The CADD pump is unique because it is portable, carried in a small bag or backpack, and applicable for home-based treatment due to its intuitive and user-friendly interface.
A patient educational program based on strategic patient involvement was integrated into supportive care practice during induction treatment at each hematology department. The program included guidance and training to the patient and/or their primary caregiver in managing the care of their CVC including drawing blood samples, how to use a positive expiratory pressure whistle, functionality of the infusion pump, how to manage and react on pump alarm, and precautions when receiving treatment while being home.
The participants could contact the hematological department from where they received their treatment 24 hours a day by telephone. They were instructed to contact their respective department immediately if fever (>38.0 Celcius) or any pump report alarm occurred. The nurses would then guide the participant to solve the problem from home or recommend they seek help at the department to solve the problem or get evaluated by a doctor.
Adverse events were categorized into non-serious adverse events and serious adverse events. Non-serious adverse events were any pump infusion alarms that could not be solved by phone and required a visit to the hospital. Serious adverse events were any adverse reactions during treatment at home, which resulted in the following outcomes: death or septic shock.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aalborg, Denmark
- Aalborg University Hospital
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Aarhus, Denmark
- Aarhus University Hospital
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Herlev, Denmark, 2730
- Herlev Hospital
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Odense, Denmark
- Odense University Hospital
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Roskilde, Denmark, 4000
- Sjællandsuniversitetshospital Roskilde
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Østerbro
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Copenhagen, Østerbro, Denmark, 2100
- Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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 Criteria:
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Feasiblity and Safety
All eligible patients will be assigned to this arm
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To investigate the feasibility and safety of home-based intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
Furthermore, we examined the quality of life (QOL) and psychological wellbeing while receiving induction and consolidation chemotherapy at home.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Infections (type)
Time Frame: Up to 24 weeks
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Data will be collected from medical charts
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Up to 24 weeks
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Infections (days)
Time Frame: Up to 24 weeks
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Data will be collected from medical charts
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Up to 24 weeks
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Recruitment rate
Time Frame: up to 3 years
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Number of participants included from eligible patients
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up to 3 years
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Adherence to intervention
Time Frame: Up to 24 weeks
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Number of weeks completed out of planned weeks of intervention
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Up to 24 weeks
|
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Hospital admissions
Time Frame: Up to 24 weeks
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Data will be collected from medical charts
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Up to 24 weeks
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Number of days home during treatment
Time Frame: Up to 24 weeks
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Data will be collected from medical charts
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Up to 24 weeks
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Number of contacts to hospital during treatment
Time Frame: Up to 24 weeks
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Data will be collected from medical charts
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Up to 24 weeks
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Number of removed CVK
Time Frame: Up to 24 weeks
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Data will be collected from medical charts
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Up to 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Psychological wellbeing
Time Frame: Change measures (baseline, 12 weeks, 24 and 36 weeks)
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Measured using the Hospital Anxiety and Depression Scale (HADS)
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Change measures (baseline, 12 weeks, 24 and 36 weeks)
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Quality of Life in participants
Time Frame: Change measures (baseline, 12 weeks, 24 and 36 weeks)
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Measured with the Functional Assessment of Cancer Therapy - Leukemia (FACT-LEU)
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Change measures (baseline, 12 weeks, 24 and 36 weeks)
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Quality of Life in participants
Time Frame: Change measures (baseline, 12 weeks, 24 and 36 weeks)
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Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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Change measures (baseline, 12 weeks, 24 and 36 weeks)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Home-Based Chemo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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