Feasiblity and Safety of Home-based Intensive Chemotherapy
- Conditions
- Acute Leukemia
- Interventions
- Other: Home-based chemotherapy
- Registration Number
- NCT04904211
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Feasiblity and Safety Home-based chemotherapy All eligible patients will be assigned to this arm
- Primary Outcome Measures
Name Time Method Number of days home during treatment Up to 24 weeks Data will be collected from medical charts
Number of removed CVK Up to 24 weeks Data will be collected from medical charts
Recruitment rate up to 3 years Number of participants included from eligible patients
Infections (type) Up to 24 weeks Data will be collected from medical charts
Adherence to intervention Up to 24 weeks Number of weeks completed out of planned weeks of intervention
Hospital admissions Up to 24 weeks Data will be collected from medical charts
Infections (days) Up to 24 weeks Data will be collected from medical charts
Number of contacts to hospital during treatment Up to 24 weeks Data will be collected from medical charts
- Secondary Outcome Measures
Name Time Method Quality of Life in participants Change measures (baseline, 12 weeks, 24 and 36 weeks) Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Psychological wellbeing Change measures (baseline, 12 weeks, 24 and 36 weeks) Measured using the Hospital Anxiety and Depression Scale (HADS)
Trial Locations
- Locations (6)
Odense University Hospital
🇩🇰Odense, Denmark
Sjællandsuniversitetshospital Roskilde
🇩🇰Roskilde, Denmark
Rigshospitalet
🇩🇰Copenhagen, Østerbro, Denmark
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Herlev Hospital
🇩🇰Herlev, Denmark