Clinical Trial on Hematologic Cancer, Acute Myeloid Leukaemia (AML), Hospital At Home, Home-based Chemotherapy - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Introduction Acute myeloid leukemia (AML) is an aggressive hematological malignancy characterized by rapid proliferation of malignant blasts in the bone marrow, leading to suppression of normal hematopoiesis and bone marrow failure. Curative treatment typically involves intensive chemotherapy, often including intravenous Cytarabine (IV-Cytarabine), administered either as intermittent or continuous infusions. Due to the need for prolonged infusion and close clinical monitoring, patients are commonly treated during hospitalization or through repeated outpatient visits. This places a considerable burden on patients, caregivers, and healthcare systems, and may increase risks associated with prolonged hospital stays, including infections, reduced mobility, impaired nutrition, and decreased quality of life. New delivery models, including portable programmable infusion pumps, make it possible for selected patients to receive IV-Cytarabine at home.

Home-based hematological care is increasingly recognized as a patient-centered model that may reduce hospital visits, support daily living, improve psychosocial well-being, and potentially lower risks related to hospitalization. Previous Danish studies have shown that home-based chemotherapy can be feasible, safe, and acceptable to patients. However, current evidence remains limited, and no national or international guidelines exist to support systematic implementation of home-based hematological treatment. Important gaps remain regarding organizational models, safety, feasibility, health economic costs, patient-reported outcomes, caregiver involvement, and long-term sustainability. Preliminary findings from the Treat@Home program indicate that home-based treatment is already used in Denmark, but access is unequal, data registration is inconsistent, and the evidence base is limited. The HOME-CALM study therefore aims to generate robust evidence on home-based IV-Cytarabine for patients with AML in Denmark. This knowledge will support the development of national recommendations and sustainable, equitable care pathways for home-based intravenous chemotherapy.

Hypothesis This study is based on the following assumptions and hypotheses.

Study 2 Home-based IV-Cytarabine treatment for patients with AML is feasible and safe when compared to inpatient or outpatient treatment settings, reducing the burden on healthcare systems and supporting everyday lives.

Study 3 Key barriers to home-based IV-Cytarabine treatment include lack of patient and caregiver education, low level of health literacy, and challenges in coordination with HCPs across sectors, while facilitators include effective communication, support systems, and tailored treatment plans.

Study 4 Key facilitators to implementing home-based IV-Cytarabine treatment are related to effective intersectoral coordination, clearly defined roles for HCPs, adequate guidelines for practice, and patient and caregiver education.

Aims The overall aim is to develop research-based evidence on feasibility, impact, and implementation of home-based interventions for AML patients receiving IV-Cytarabine in Denmark, which will result in a national guideline for home-based intravenous chemotherapy treatment. These goals will be accomplished by investigating practice, safety, organizational frameworks, health economic costs, and associated barriers and facilitators in delivering and managing home-based IV-Cytarabine treatment in this population.

Specific study aims are:

Study 1 To summarize the existing research-based evidence on home-based interventions with chemotherapy treatment. Specifically, it aims to identify, collate, and assess studies that investigate the feasibility and safety of home-based interventions with chemotherapy, their influence on symptoms and quality of life, and their impact on cost-effectiveness in patients with hematological malignancies.

Study 2 To evaluate the feasibility of implementing home-based treatment with Cytarabine to patients with acute leukemia in Denmark. Further to examine the costs associated with a home-based treatment with Cytarabine in a clinical setting, and to examine QoL, symptoms and health literacy in patients as well as roles and responsibilities in their caregivers, while receiving treatment at home

Study 3 To explore the experiences and perspectives on barriers and facilitators during home-based treatment with Cytarabine among patients, caregivers, and HCPs across health sectors.

Study 4 To develop and deploy strategies at a national level to support and enhance the adoption and long-term sustainability of home-based treatment with Cytarabine to patients with acute leukemia. Specifically, to develop evidence-based recommendations to optimize delivery, ensure scalability, and promote equitable access across diverse healthcare settings.

Methods A multimethod design will be applied in that both quantitative and qualitative methods will be used to strengthen the types of data material and to adequately answer the research aims. This research protocol is inspired by the methodological framework for developing and evaluating complex interventions described by the Medical Research Council (MRC). Complex intervention research consists of multiple phases (identification, feasibility, evaluation, and implementation) ensuring that core elements essential to the research process are addressed. Home-based treatment is classified as a complex intervention, and by using an already implemented intervention aligns with the MRC iterative nature, focusing on evaluating, optimizing, and scaling complex interventions in real-world contexts. This approach not only leverages existing evidence but also ensures practical, ethical, and resource-efficient research that can directly inform policy and practice. Consequently, this protocol consists of four studies representing the MRC framework´s four phases. In accordance with the MRC framework, knowledge gained from study 1 will inform study 2 and 3, and findings from study 2 and study 3 will inform study 4.

Identification:

Study 1 will identifying the current international evidence and practice of home-based treatment.

Feasibility:

Study 2 will assess the feasibility, safety, organization, and health economic costs home-based treatments with IV-Cytarabine.

Evaluation:

Study 3 will evaluate home-based treatment using a qualitative design to gain a comprehensive understanding of the intervention´s impact, facilitating more effective implementation and refinement.

Implementation:

Finally, using an implementation framework study 4 will evaluates implementation of home-based treatment focusing on its adaptation, optimization, sustainability, and scalability.

Overview of evidence. An initial step will be to provide a comprehensive overview of the current research-based evidence on home-based chemotherapy interventions for patients with hematological malignancies. Specifically, the investigators will identify, collate, and critically assess existing studies that examine the feasibility, safety, and impact of such interventions on patient-reported outcomes, including symptoms, quality of life, and cost-effectiveness. These findings will serve as a foundational evidence base to guide the subsequent studies. Specifically, it will inform the design and focus of the feasibility evaluation in Study 2 by highlighting best practices, gaps in current knowledge, and key implementation challenges reported in prior research. Moreover, insights into the contextual factors and outcomes of home-based chemotherapy from diverse healthcare settings will contribute to a deeper understanding of potential facilitators and barriers, which will be further explored through qualitative methods in Study 3.

Feasibility approach. The study will adopt the Consolidated Framework for Implementation Research (CFIR) as our overall framework for the evaluation. CFIR consists of five major domains: Intervention Characteristics, Outer Setting, Inner Setting, Characteristics of Individuals, and Process. It includes a total of 39 constructs that facilitate a comprehensive analysis of both barriers and facilitators to implementation. In cancer research, the primary objective is to implement evidence-based interventions that demonstrate effectiveness. Efficacy studies assess intervention outcomes under ideal conditions, whereas effectiveness studies evaluate how well interventions perform in real-world, less controlled settings. The UK's National Institute for Health Research differentiates between feasibility studies and pilot studies. Feasibility studies explore whether a study is possible to carry out, while pilot studies serve as small-scale versions of the main study. Feasibility studies, therefore, aim to assess the development and implementation process of an intervention and help determine whether it is appropriate to proceed with efficacy testing. The feasibility approach is crucial because, although home-based treatment is widely implemented, it lacks strategic implementation strategies, leading to unequal access, limited evidence, and inconsistent data recording across the country. At the same time, there is no existing evidence on effective implementation practices in this area.

Qualitative approach. Qualitative methods will be employed to explore human experiences and actions within their social contexts, thereby facilitating a deeper understanding of the phenomena under investigation. The aim of study 3 is to gain insight into the experiences and perspectives of patients, caregivers, and HCPs across health sectors involved in home-based treatment with the goal of generating new knowledge about the nature and impact of barriers and facilitators during home-based treatment with Cytarabine.

Study description - Study 1:

Aim. To summarize the existing research-based evidence on home-based interventions with chemotherapy treatment, and its influence on symptoms and quality of life in patients with hematological malignancies.

Design and methods. This systematic review will follow the PRISMA guidelines: "Preferred Reporting Items for Systematic Reviews and Meta-Analysis" (Page et al. 2021).

The study will be registered at the international register of systematic reviews PROSPERO.

Search strategy Four databases will be searched from 2004 to 2024: Public Medline (MEDLINE/PUBMED), EMBASE, Cumulative Index of Nursing and Allied Health (CINAHL) and APA PsycINFO (PSYCINFO). The search strategy will be developed using a matrix based on the principles from PICO (Population, intervention, control, and outcome), and will comply into three search focuses (population, intervention and outcomes). The matrix will consistently be applied to all selected databases and include 1) Hematological malignancies (population), 2) Home-based chemotherapy treatment (Intervention), and 3) Cost-effectiveness analysis and/or symptoms and/or quality of life (Outcomes). A combination of MeSH terms, thesaurus, indexed terms, and free text for the three search focuses will be used. An academic librarian before initiation will validate the search strategy. In addition, PROSPERO will be searched for ongoing systematic reviews related to the scope of this systematic review.

Eligibility criteria and outcomes Studies are eligible for inclusion in this systematic review if they meet the following criteria: 1) Enrolled patients > 18 years with a hematological malignancy regardless of stage or type of treatment 2) Investigate home-based interventions with chemotherapy treatment, 3) Included the following outcomes: disease and treatment-related symptoms and/or QOL measured on validated questionnaires and/or Cost-effectiveness analysis.

Study selection and quality assessment. Covidence will be used to manage and screen all studies considered relevant and are then read in full. The studies are then categorized as either included, unclear (for further discussion), or excluded based on the inclusion criteria. Any discrepancies relating to whether a paper should be included in the review will be discussed by the reviewers. If no agreement could be achieved, then this will be discussed at team meetings by the entire team until consensus are reached. In case of overlapping data sets presented in different studies, the most resent publications will be included. Critical Appraisal Checklists (CASP) will be used to evaluate the methodological quality and assessed risk of bias in the included studies. The following information will systematically be extracted from all the included articles: study authors, date of publication, study population and participant characteristics (sample size, age, gender, country of origin, type of hematologic malignancy, study methodology, setting and duration), method of outcome measurement, study outcomes and results. Where possible, data on experimental conditions, including the number of study arms, name and description of intervention(s) and comparator(s) groups will also be extracted.

Data extraction. The study will not do a meta-analysis because of expected heterogeneity in design and outcomes across the small number of existing trials. Instead, the researchers involved will synthesize outcomes using a narrative approach including tables and figures to aid in data presentation where appropriate. These data will be extracted independently by 2-4 researchers, and after discussion rounds, all researchers will agree upon the finalized version of the synthesized data. The following outcomes will be synthesized; feasibility (satisfaction, challenges) and safety (hospital admissions, adverse events), outcomes (symptoms and quality of life), and cost-effectiveness measures (number of saved visits to hospital/inpatient days), infusion (type of CVC, continuous vs bolus), who administer the treatment (patient, caregiver, health professional), where are the treatment administered (hospital, home).

Synthesis The Synthesis Without Meta-analysis (SWiM) guideline will be used to promote transparent reporting. To obtain clinical applicability, studies will be grouped primarily based on the basis of type of treatment administered at home.

Study description - study 2:

Aim. To evaluate the feasibility of implementing home-based treatment with IV-Cytarabine to patients with AML in Denmark. Further to examine the costs associated with a home-based treatment with IV-Cytarabine in clinical settings, and to examine QoL, symptoms and health literacy in patients as well as roles and responsibilities for their caregivers, while receiving treatment at home.

Design and methods. This is a single-arm prospective observational feasibility study for patients diagnosed with acute myeloid leukemia receiving treatment with IV-Cytarabine either as stand-alone treatment or in combination, in a real-world, standard practice setting. The study will be conducted in accordance with The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies.

Study population. Participants that have been 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 defined as an 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 otherwise deemed unethical to participate due to mental disability, are ineligible for inclusion in the study.

Recruitment procedure. Patients and their primary caregiver, identified by patients, will be recruited from all Danish hematologic departments offering home-based IV-Cytarabine treatment: Copenhagen University Hospital, Odense University Hospital, and Zealand University Hospital.

Data collection timepoints are defined in accordance with the treatment regimen, ensuring consistency across sites and comparability of outcomes. The study will observe both induction- and consolidation phase. If the patients are hospitalized during initial or following treatments, data will still be collected, however, time-utilization will not be assessed. Specifically, assessments are scheduled at

Cycle 1

Treatment Initiation (C1TI, t0),
Treatment Completion (C1TC, t1)
Hematological Recovery (C1HR, t2)

Cycle 2

Treatment Initiation (C2TI, t3)
Treatment Completion (C2TC, t4)
Hematological Recovery (C2HR, t5)

Cycle 3

Treatment Initiation (C3TI, t6)
Treatment Completion (C3TC, t7)
Hematological Recovery (C3HR, t8)

Cycle 4

Treatment Initiation (C4TI, t9)
Treatment Completion (C4TC, t10)
Hematological Recovery (C4HR,

These timepoints are anchored to key clinical events within the treatment cycles, thereby reflecting relevant changes in patient status and treatment progression.

Primary outcomes. The primary outcomes are feasibility outcomes related to home-based treatment with IV-Cytarabine in a real-world clinical setting. Feasibility will be evaluated through recruitment, adherence, retention, acceptability, practicability, safety, and cost-effectiveness.

Acceptability will be assessed using the Theoretical Framework of Acceptability questionnaire, which evaluates affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy.

Secondary outcomes. Quality of life will be assessed using the EORTC QLQ-C30.

Health literacy will be assessed using the Danish version of the Health Literacy Questionnaire.

Caregiver roles and responsibilities will be assessed using the Caregiver Roles and Responsibilities Scale.

Patient and caregiver experiences of time and energy expenditure related to home-based treatment will be assessed using a self-developed questionnaire.

Symptoms and patient-reported safety outcomes will be assessed using the EORTC QLQ-C30 and supplemented by clinical data from electronic health records.

Health economic outcomes will include healthcare and non-healthcare resource use. This includes healthcare professional time, use of CADD pumps and materials, training of staff, patients and caregivers, number of hospital contacts, inpatient and outpatient visits, virtual contacts, and treatment administrations at home or in hospital.

Baseline data. Baseline data will include patient demographics, clinical characteristics, AML type, previous treatment, prescribed treatment regimen, and relevant blood test results. Caregiver baseline data will include demographic information and information on family and employment status.

Patient-reported outcomes will be collected electronically via e-Boks at baseline, C2TC, C4TC, and at the end of IV-Cytarabine treatment. The TFA questionnaire will be collected at C2TC, C4TC, and at end of treatment. If participants are unable to complete the questionnaires electronically, project staff will assist by telephone.

Safety and support. Safety data will be collected continuously throughout study participation. Adverse events and serious adverse events will be classified according to CTCAE version 5.0. Particular attention will be given to infections, complications requiring hospital-based intervention, treatment delays, interruptions, and issues related to home administration.

Data on deviations from the planned treatment pathway, including clinical complications, technological issues, logistical challenges, or return to hospital care, will be collected from electronic health records and telephone interviews.

Analysis. Feasibility outcomes, safety data, patient-reported outcomes, and health economic data will primarily be analyzed using descriptive statistics. Categorical variables will be summarized as numbers and percentages, and continuous variables as means with standard deviations or medians with ranges, depending on data distribution.

Sample size. Based on methodological guidance for pilot and feasibility studies, the above-described rules of thumb, and considering practical constraints, the study aim to recruit 15 participants per site, in total 75 participants. This sample is expected to provide sufficient information to estimate key feasibility parameters with reasonable precision and allows us to explore variability in implementation processes across the included departments. While a relatively balanced contribution across regions is preferred to support exploration of variability in implementation processes, recruitment targets should be considered pragmatic rather than fixed quotas, acknowledging potential differences in patient volume and eligibility across sites.

Ethical considerations.

The study will be conducted in accordance with the Declaration of Helsinki and the General Data Protection Regulation (GDPR) as implemented under Danish law. The project has been assessed by the Regional Committees on Health Research Ethics (VEK) and found not to be notifiable to the Danish research ethics committee system, cf. Section 14(1) of the Danish Act on Research Ethics Review of Health Research Projects [case number S-20262000 - 121].

Participation is voluntary, and written informed consent will be obtained from all participants prior to inclusion. The study population is considered vulnerable, and efforts will be made to minimize participant burden and ensure that study activities do not interfere with treatment or add unnecessary stress to patients or caregivers. Participants may withdraw at any time without consequences for their current or future treatment.

Data will be handled confidentially and stored securely in accordance with Danish data protection requirements. Personal identifiers will be removed from datasets, access will be restricted to authorized research personnel, and results will be reported in aggregate form to ensure participant anonymity.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Christian Landbo, MSc Global Health/PhD Student
Phone Number: +4547324816
Email: clandb@regionsjaelland.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of retention to standard protocol in patients receiving home-based treatment. Time Frame: Through study completion, an average of 20 weeks per patient.	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 Time Frame: From date of inclusion, up to 20 weeks	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 Time Frame: From date of inclusion, up to 20 weeks	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 Time Frame: From date of inclusion, up to 20 weeks	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 Time Frame: Through study completion, an average of 24 weeks	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 Time Frame: Through study completion, an average of 20 weeks per patient	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 Time Frame: At the end of Cycle 1, 2, 3 & 4 (each cycle is 5-10 days)	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 Time Frame: At the end of Cycle 1, 2, 3 & 4 (each cycle is 5-10 days)	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 Time Frame: At the end of Cycle 1, 2, 3 & 4 (each cycle is 5-10 days)	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 Time Frame: At the end of Cycle 1, 2, 3 & 4 (each cycle is 5-10 days)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health-related quality of life assessed using the EORTC QLQ-C30 Time Frame: Baseline (Day 1) and at the end of Cycle 2 & 4 (each cycle is 5-10 days)	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.	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 Time Frame: Baseline (Day 1) and at the end of Cycle 2 & 4 (each cycle is 5-10 days)	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.	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 Time Frame: Baseline (Day 1) and at the end of Cycle 2 & 4 (each cycle is 5-10 days)	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.	Baseline (Day 1) and at the end of Cycle 2 & 4 (each cycle is 5-10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

Odense University Hospital

Rigshospitalet, Denmark

Investigators

Study Director: Kristina Holmegaard Nørskov, PhD, Assoc. Prof., University of Southern Denmark & Zealand University Hospital
Principal Investigator: Christian Landbo, MSc Global Health, University of Southern Denmark & Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 17, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

January 30, 2029

Study Registration Dates

First Submitted

July 25, 2026

First Submitted That Met QC Criteria

September 2, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)