Clinical trial · Observational
Home-based Intravenous Cytarabine Treatment for Acute Myeloid Leukemia: a National Danish Study of Feasibility, Costs, and Implementation
Home-CALM Home-based Treatment With Intravenous Cytarabine for Acute Myeloid Leukemia: Feasibility, Health Economics, Barriers and Facilitators - a National Multicenter Study in Denmark
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational multicenter feasibility and implementation study is to evaluate home-based treatment with intravenous Cytarabine for patients with acute myeloid leukemia in Denmark. The study aims to generate research-based evidence on feasibility, safety, patient impact, health economic costs, and implementation of home-based intravenous chemotherapy treatment. The main questions it aims to answer are: 1\. What is the existing evidence on home-based chemotherapy treatment for patients with hematological malignancies, including feasibility, safety, symptoms, quality of life, and cost-effectiveness? 2\. Is home-based treatment with intravenous Cytarabine feasible and safe for patients with acute myeloid leukemia in Denmark? 3\. What are the costs, patient-reported outcomes, and caregiver roles related to home-based Cytarabine treatment? 4\. What are the key barriers and facilitators experienced by patients, caregivers, and healthcare professionals during home-based Cytarabine treatment? Which national strategies and recommendations can support the implementation, scalability, sustainability, and equitable access to home-based intravenous Cytarabine treatment across healthcare settings in Denmark?
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukaemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hematologic Cancer | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Home-based Chemotherapy | — | UNRESOLVED | — |
| Hospital At Home | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (10)
- measure
- Rates of retention to standard protocol in patients receiving home-based treatment.
- timeFrame
- Through study completion, an average of 20 weeks per patient.
- description
- Retention will be measured as the proportion of patients who remain in the standard home-based treatment protocol until completion of the planned treatment course. The retention rate will be calculated as: Number of patients who complete the planned home-based treatment protocol / Number of patients who initiate home-based treatment × 100. Non-retention is defined as any deviation from the site-specified standard home-based treatment protocol resulting in temporary or permanent interruption of home-based treatment and transition to hospital-based treatment, either temporarily or permanently.
- measure
- Number and proportion of treatment doses administered at home, administered at the hospital, diverted from home to hospital, or not administered
- timeFrame
- From date of inclusion, up to 20 weeks
- description
- Treatment delivery will be assessed by recording the location of administration for each planned treatment dose via EHJ. Doses will be categorized as: * Administered at home as planned * Administered at the hospital as planned * Diverted from home to hospital, defined as a dose planned for home administration but administered at the hospital * Not administered/missed doses The number and proportion of doses in each category will be calculated relative to the total number of planned treatment doses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: PATIENT (Study 2+3) * Age ≥ 18 years * Can provide informed consent. * Participants that have been diagnosed with AML, to receive IV-Cytarabine CAREGIVER (Study 2+3) * Age ≥18 years * Can provide informed consent. HEALTHCARE PROFESSIONALS (Study 3) * Employed as Physician or Registered Nurse * Work experience with home-based treatment for patients with AML for minimum 1 year. Exclusion Criteria (Patient/Caregiver): * Inability to read, write and/or speak Danish or English * Otherwise deemed unethical to participate due to mental disability
References
Publications (0)
Data not yet available