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?
Age ≥ 18 years
Can provide informed consent.
Participants that have been diagnosed with AML, to receive IV-Cytarabine
Age ≥18 years
Inability to read, write and/or speak Danish or English
Otherwise deemed unethical to participate due to mental disability
Study 2: Participants diagnosed with AML, aged ≥ 18 years, who are to receive treatment with IV-Cytarabine and their appointed primary caregiver, who can provide informed consent are eligible for inclusion. A primary caregiver is a individual providing frequent support and attending to the physical and emotional needs of someone requiring ongoing assistance. Inability to read, write and/or speak Danish or English, or deemed unethical to participate due to mental disability, are ineligible for inclusion in the study. Patients and their primary caregiver, identified by patients, will be recruited from all Danish hematologic departments offering home-based IV-Cytarabine treatment: Aarhus University Hospital, Aalborg University Hospital, Copenhagen University Hospital, Odense University Hospital, and Zealand University Hospital.
Case-only
Prospective
Not listed
Rates of retention to standard protocol in patients receiving home-based treatment.
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.
Number and proportion of treatment doses administered at home, administered at the hospital, diverted from home to hospital, or not administered
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.
Non-adherence to treatment protocol
Non-adherence will be assessed as any deviation from the planned treatment or the site-specific eligibility and delivery criteria for home-based treatment. For each deviation, the primary reason will be recorded and categorized as: Clinical Logistical Technical Patient-related Organizational Other Deviations may result in a planned home-based dose being administered at the hospital, temporary or permanent interruption of home-based treatment, permanent transition to hospital-based treatment, or non-administration of a planned dose. The number and proportion of deviations within each category will be reported.
Rate of transition from home-based to hospital-based treatment
The number and proportion of patients who transition from home-based treatment to hospital-based treatment/vice versa, during the treatment course. Transitions will be classified as temporary or permanent and recorded according to the reason for transition. Also, the number and proportion of nights spent at home during treatment and the number and proportion of treatment cycles completed without hospital admission or hospital visits will be registered as well. Planned hospital admissions or visits specified in the site-specific treatment protocol will not be included in this outcome.
Change in health-related quality of life assessed using the EORTC QLQ-C30
Patients' health-related quality of life will be assessed using the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are transformed to a scale from 0 to 100. Higher scores on the global health status and functioning scales indicate better quality of life and functioning, whereas higher scores on the symptom scales indicate greater symptom burden.
Change in patient health literacy assessed using the Health Literacy Questionnaire
Patients' health literacy will be assessed using the 44-item Health Literacy Questionnaire (HLQ), which comprises nine independent health-literacy domains. A mean score will be calculated separately for each domain; no overall HLQ score will be calculated. Domains 1-5 are scored from 1 to 4, and domains 6-9 from 1 to 5. Higher scores indicate greater health-literacy strengths and capabilities.
Change in caregiver well-being assessed using the Caregiver Roles and Responsibilities Scale
The impact of caregiving on informal caregivers will be assessed using the Caregiver Roles and Responsibilities Scale (CRRS). The questionnaire evaluates support and impact, lifestyle, emotional health and well-being, self-care, and financial well-being. Subscale and total scores will be calculated according to the CRRS scoring guidelines. Higher scores indicate better caregiver quality of life and a lower adverse impact of caregiving.
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Zealand University Hospital
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Odense University Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
