Acute LeukemiaNCT04904211
Feasiblity and Safety of Home-based Intensive Chemotherapy
A study testing Home-based chemotherapy in people with Acute Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
Trial summary
a multicenter single-arm feasibility and safety study of home-based intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia and their quality of life and psychological wellbeing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Home-based chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 6 sitesDenmark
- Study dates
- Jan 2017to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 During the intervention, participants were withdrawn if hospitalized in an intensive care unit for more than two weeks, if they had a psychological condition (delirium or severe depression), or in case of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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Rigshospitalet
Copenhagen, Østerbro, 2100
Herlev Hospital
Herlev, 2730
Odense University Hospital
Odense
Sjællandsuniversitetshospital Roskilde
Roskilde, 4000
About this study
Official title: A National Danish Proof of Concept on Feasiblity and Safety of Home-based Intensive Chemotherapy in Patients With Acute Leukemia.
a multicenter single-arm feasibility and safety study of home-based intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia and their quality of life and psychological wellbeing. This national study included patients from six sites in Denmark who received intensive chemotherapy on programmed CADD Solis infusion pumps through a central venous catheter and were also managed as outpatients during treatment-induced pancytopenia.
Read the 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.
- Conditions
- Acute Leukemia
- Being tested
- Home-based chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based chemotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Feasiblity and Safety | Experimental | All eligible patients will be assigned to this arm Receives: Other: Home-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants included from eligible patients
Measured: up to 3 years
Adherence to intervention
Number of weeks completed out of planned weeks of intervention
Measured: Up to 24 weeks
Hospital admissions
Data will be collected from medical charts
Measured: Up to 24 weeks
Infections (days)
Data will be collected from medical charts
Measured: Up to 24 weeks
Infections (type)
Data will be collected from medical charts
Measured: Up to 24 weeks
Number of days home during treatment
Data will be collected from medical charts
Measured: Up to 24 weeks
Number of contacts to hospital during treatment
Data will be collected from medical charts
Measured: Up to 24 weeks
Number of removed CVK
Data will be collected from medical charts
Measured: Up to 24 weeks
Secondary outcomes (3)
Psychological wellbeing
Measured using the Hospital Anxiety and Depression Scale (HADS)
Measured: Change measures (baseline, 12 weeks, 24 and 36 weeks)
Quality of Life in participants
Measured with the Functional Assessment of Cancer Therapy - Leukemia (FACT-LEU)
Measured: Change measures (baseline, 12 weeks, 24 and 36 weeks)
Quality of Life in participants
Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Measured: Change measures (baseline, 12 weeks, 24 and 36 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study startJan 2017
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Holmegaard Nørskov, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904211
- Sponsor's protocol ID
- Home-Based Chemo
- Status last verified
- May 2021
- First submitted
- 22 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norskov KH, Fridthjof K, Kampmann P, Dunweber A, Andersen CL, Renaberg T, Schollkopf C, Ahmad SA, Schou K, Jensen CF, Moller P, Lundholm BW, Marcher C, Jepsen L, Orntoft AK, Ommen HB, Andersen L, Behrentzs A, Hasselgren CF, Severinsen M, Grand MK, Jarden M, Moller T, Kjeldsen L. A national Danish proof of concept on feasibility and safety of home -based intensive chemotherapy in patients with acute myeloid leukemia. Leuk Res. 2022 Jan;112:106756. doi: 10.1016/j.leukres.2021.106756. Epub 2021 Nov 22.
PubMed 34839055
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Danish Proof of Concept on Feasiblity and Safety of Home-based Intensive Chemotherapy in Patients With Acute Leukemia.
- ClinicalTrials.gov ID
- NCT04904211
- Acronym / sponsor ID
- Home-Based Chemo
- Conditions
- Acute Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
a multicenter single-arm feasibility and safety study of home-based intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia and their quality of life and psychological wellbeing. This national study included patients from six sites in Denmark who received intensive chemotherapy on programmed CADD Solis infusion pumps through a central venous catheter and were also managed as outpatients during treatment-induced pancytopenia.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasiblity and Safety | Experimental | Other: Home-based chemotherapyAll eligible patients will be assigned to this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based chemotherapyTo 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. | Other | Feasiblity and Safety |
Primary outcome
Recruitment rate
Time frame: up to 3 years
Number of participants included from eligible patients
Adherence to intervention
Time frame: Up to 24 weeks
Number of weeks completed out of planned weeks of intervention
Hospital admissions
Time frame: Up to 24 weeks
Data will be collected from medical charts
Infections (days)
Time frame: Up to 24 weeks
Data will be collected from medical charts
Infections (type)
Time frame: Up to 24 weeks
Data will be collected from medical charts
Number of days home during treatment
Time frame: Up to 24 weeks
Data will be collected from medical charts
Number of contacts to hospital during treatment
Time frame: Up to 24 weeks
Data will be collected from medical charts
Number of removed CVK
Time frame: Up to 24 weeks
Data will be collected from medical charts
3 secondary outcomes
Psychological wellbeing
Time frame: Change measures (baseline, 12 weeks, 24 and 36 weeks)
Quality of Life in participants
Time frame: Change measures (baseline, 12 weeks, 24 and 36 weeks)
Quality of Life in participants
Time frame: Change measures (baseline, 12 weeks, 24 and 36 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 34839055Norskov KH, Fridthjof K, Kampmann P, Dunweber A, Andersen CL, Renaberg T, Schollkopf C, Ahmad SA, Schou K, Jensen CF, Moller P, Lundholm BW, Marcher C, Jepsen L, Orntoft AK, Ommen HB, Andersen L, Behrentzs A, Hasselgren CF, Severinsen M, Grand MK, Jarden M, Moller T, Kjeldsen L. A national Danish proof of concept on feasibility and safety of home -based intensive chemotherapy in patients with acute myeloid leukemia. Leuk Res. 2022 Jan;112:106756. doi: 10.1016/j.leukres.2021.106756. Epub 2021 Nov 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based chemotherapy in people with Acute Leukemia, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: up to 3 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04904211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.