Feasiblity and Safety of Home-based Intensive Chemotherapy

Acute Leukemia Clinical Trial

Official title:

A National Danish Proof of Concept on Feasiblity and Safety of Home-based Intensive Chemotherapy in Patients With Acute Leukemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04904211
• Other study ID #: Home-Based Chemo
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: September 2020

Study information

• Verified date: May 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Related Conditions & MeSH terms

• Acute Leukemia
• Leukemia

Intervention

Other:
• Home-based chemotherapy
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.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen	Østerbro
Denmark	Herlev Hospital	Herlev
Denmark	Odense University Hospital	Odense
Denmark	Sjællandsuniversitetshospital Roskilde	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Number of participants included from eligible patients	up to 3 years
Primary	Adherence to intervention	Number of weeks completed out of planned weeks of intervention	Up to 24 weeks
Primary	Hospital admissions	Data will be collected from medical charts	Up to 24 weeks
Primary	Infections (days)	Data will be collected from medical charts	Up to 24 weeks
Primary	Infections (type)	Data will be collected from medical charts	Up to 24 weeks
Primary	Number of days home during treatment	Data will be collected from medical charts	Up to 24 weeks
Primary	Number of contacts to hospital during treatment	Data will be collected from medical charts	Up to 24 weeks
Primary	Number of removed CVK	Data will be collected from medical charts	Up to 24 weeks
Secondary	Psychological wellbeing	Measured using the Hospital Anxiety and Depression Scale (HADS)	Change measures (baseline, 12 weeks, 24 and 36 weeks)
Secondary	Quality of Life in participants	Measured with the Functional Assessment of Cancer Therapy - Leukemia (FACT-LEU)	Change measures (baseline, 12 weeks, 24 and 36 weeks)
Secondary	Quality of Life in participants	Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	Change measures (baseline, 12 weeks, 24 and 36 weeks)