Feasiblity and Safety of Home-based Intensive Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Acute Leukemia
• Intervention / Treatment: Other: Home-based chemotherapy

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Aarhus, Denmark
    • Aarhus University Hospital
  • Herlev, Denmark, 2730
    • Herlev Hospital
  • Odense, Denmark
    • Odense University Hospital
  • Roskilde, Denmark, 4000
    • Sjællandsuniversitetshospital Roskilde
  • Østerbro
    • Copenhagen, Østerbro, Denmark, 2100
      • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feasiblity and Safety; All eligible patients will be assigned to this arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infections (type)	Data will be collected from medical charts	Up to 24 weeks
Infections (days)	Data will be collected from medical charts	Up to 24 weeks
Recruitment rate	Number of participants included from eligible patients	up to 3 years
Adherence to intervention	Number of weeks completed out of planned weeks of intervention	Up to 24 weeks
Hospital admissions	Data will be collected from medical charts	Up to 24 weeks
Number of days home during treatment	Data will be collected from medical charts	Up to 24 weeks
Number of contacts to hospital during treatment	Data will be collected from medical charts	Up to 24 weeks
Number of removed CVK	Data will be collected from medical charts	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological wellbeing	Measured using the Hospital Anxiety and Depression Scale (HADS)	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)	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)	Change measures (baseline, 12 weeks, 24 and 36 weeks)

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: May 22, 2021
• First Submitted That Met QC Criteria: May 22, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 22, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: Home-Based Chemo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No