Home-based Intravenous Cytarabine Treatment for Acute Myeloid Leukemia: a National Danish Study of Feasibility, Costs, and Implementation

NCT07802015 | Not Yet Recruiting

• 1 other identifier: ZUH:HOME-CALM
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Hematologic Cancer; Acute Myeloid Leukaemia (AML); Hospital At Home; Home-based Chemotherapy

Keywords

Implementation Science; Cost Analysis; Feasibility Studies; Safety and effectiveness

Outcome Measures

Primary Outcomes (10)

• 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.

  Through study completion, an average of 20 weeks per patient.

• 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.

  From date of inclusion, up to 20 weeks

• 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.

  From date of inclusion, up to 20 weeks

• 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.

  From date of inclusion, up to 20 weeks

• Total healthcare-sector costs associated with home-based IV-cytarabine treatment

  Total healthcare-sector costs will be estimated for each participant based on healthcare resource use during the treatment period. Costs will include implementation activities, healthcare professional time, training, equipment and materials, home-based treatment administrations, virtual contacts, inpatient and outpatient visits, hospital admissions, and unscheduled healthcare contacts. Resource use will be estimated, based on observations and informal expert interviews. Costs will bereported in US Dollars.

  Through study completion, an average of 24 weeks

• Incidence and characteristics of selected adverse events during home-based IV-cytarabine treatment

  Safety will be assessed by the number and proportion of participants experiencing selected adverse events, classified and graded according to the Common Terminology Criteria for Adverse Events, version 6.0 (CTCAE v6.0). For each event, the following information will be recorded: * Date of onset and resolution * CTCAE term and grade * Description of the event * Treatment location at the time of the event * Hospital admission and discharge dates * Oral or intravenous antibiotic treatment * Impact on home-based treatment, including interruption, delay, or transition to hospital-based treatment * Cause of treatment interruption or delay * Mitigation measures implemented and their effectiveness * Clinical outcome of the event Relevant laboratory results, including hemoglobin, leukocyte count, neutrophil count, platelet count, and C-reactive protein, will be recorded in relation to the event.

  Through study completion, an average of 20 weeks per patient

• Patient and caregiver acceptability

  Acceptability of home-based chemotherapy will be assessed using an eight-item questionnaire based on the Theoretical Framework of Acceptability (TFA). The questionnaire evaluates patients' and caregivers' perceptions, satisfaction, and emotional responses related to home-based chemotherapy. Each item is rated on a 5-point Likert scale: 1 ("Not at all"), 2 ("Not really"), 3 ("No opinion"), 4 ("Somewhat"), and 5 ("Very much"). Higher scores indicate greater acceptability of home-based chemotherapy. If the patient is not receiving home-based chemotherapy treatment, acceptability data will not be collected of that specific treatment cycle.

  At the end of Cycle 1, 2, 3 & 4 (each cycle is 5-10 days)

• Patient and caregiver time

  Non-healthcare resource use among patients and caregivers will be assessed by recording treatment-related transportation via a self-developed questionnaire. For patients and caregivers, data pertaining to treatment-related time, including preparation for treatment visits, attendance at the treatment, waiting time, and time spent on treatment at-home, will be collected

  At the end of Cycle 1, 2, 3 & 4 (each cycle is 5-10 days)

• Patient and caregiver transportation

  Non-healthcare resource use among patients and caregivers will be assessed by recording treatment-related transportation via a self-developed questionnaire. For patients and caregivers, transportation mode, number of treatment-related journeys, travel time, including public transportation, private vehicle use, patient transport services, and parking, will be recorded. Special for caregivers, data pertaining assistance with home-based treatment, and other informal care or treatment-related support will be collected.

  At the end of Cycle 1, 2, 3 & 4 (each cycle is 5-10 days)

• Patient and caregiver informal care

  For caregivers, time spent on activities pertaining to informal care or treatment-related support at-home will be collected.

  At the end of Cycle 1, 2, 3 & 4 (each cycle is 5-10 days)

Secondary Outcomes (3)

• Change in health-related quality of life assessed using the EORTC QLQ-C30

  Baseline (Day 1) and at the end of Cycle 2 & 4 (each cycle is 5-10 days)

• Change in patient health literacy assessed using the Health Literacy Questionnaire

  Baseline (Day 1) and at the end of Cycle 2 & 4 (each cycle is 5-10 days)

• Change in caregiver well-being assessed using the Caregiver Roles and Responsibilities Scale

  Baseline (Day 1) and at the end of Cycle 2 & 4 (each cycle is 5-10 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to read, write and/or speak Danish or English
• Otherwise deemed unethical to participate due to mental disability

Sponsors & Collaborators

• Zealand University Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Odense University Hospital: collaborator

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type

Study Officials

• Kristina Holmegaard Nørskov, PhD, Assoc. Prof.

  University of Southern Denmark & Zealand University Hospital

  STUDY DIRECTOR

• Christian Landbo, MSc Global Health

  University of Southern Denmark & Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Landbo, MSc Global Health/PhD Student

CONTACT

+4547324816; clandb@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: September 3, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): January 30, 2029
• Last Updated: September 3, 2026

Record last verified: 2026-07