About this trial
Introduction:
The number of diagnosed cancers is systematically increasing every year. Cancer patients need to undergo regular blood tests to monitor safety and eligibility for treatment. In case of poor blood results, the chemotherapy session must be omitted. For patients living far from the center, this means unnecessary travel with involvement of helpers, additional costs, increased potential of hospital acquired infections, and frustration associated with missed opportunity for treatment.
Aims:
The primary aim of this study is to gain knowledge about successful implementation of remote, home monitoring of complete blood count to cancer patients during and after systemic treatment for cancer. The secondary aim of the AMBeR collective study protocol is to pilot new technology, gain more context around future investigations and verify costs and changes in patient treatment pathways.
Methodology:
The investigators will test implementation of home blood monitoring in three South Baltic Countries (DK, PL, GER). Each site will participate in the implementation study with study group á n=33 (total n=165) and control group n=20 (total n=100). The duration of the study is planned for 4 cycles of chemotherapy for each patient and a 3-month follow up period. The first cycle of learning and training at the Outpatient Daily Clinic, then the remaining 3 cycles of blood monitoring at home. The average cycle length is 21-30 days, number of measurements will be determined individually depending on the diagnosis. At a baseline, after 4 cycles of chemotherapy (12-16 weeks) and after a 3-month follow-up period, parallel studies will be carried out in both the study and control groups, using mixed methods the investigators will assess outcomes of reach, effectiveness, adoption, implementation and maintenance (RE-AIM).
Expected benefits:
Implementation of the AMBeR study should reduce the amount of unnecessary and nontherapeutic hospital visits and improve manageability and independence of the patients. The investigators believe that the decrease in the number of hospital visits will diminish the risk of infection for vulnerable individuals, as well as save costs for patients and hospitals. These factors will also translate into better logistics of chemotherapy units, decreased carbon-dioxide trail, and improved quality of life and patient empowerment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
legally competent patients
aged 18 or older
diagnosed with cancer (ICD-10: C00* - C97*)
enrolled at the Department of Oncology/Hematology for outpatients
Disqualifiers
inability to give informed consent due to mental capacity or language barrier
patient unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
known bleeding disorder
bad circulation preventing the patient from getting enough blood drops to perform the test
Trial population
Eligible patients are patients that suffer from cancer, require outpatient chemotherapy, and have sufficient manual skills and good eyesight to independently perform home blood monitoring, and sufficient cognitive skills to operate POCT and transfer data.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Patient's perspectives on determinants assessed by Group Concept Mapping
Following completion or in the final phase of the pilot study, the investigators will examine the perspectives of patients on important determinants of engagement in remote home blood monitoring using the Group Concept Mapping technique. The process will follow 5 pre-described steps and all activity will be online utilizing the software Groupwisdom. The steps are as follows: 1. Brainstorming 2. Sorting and labelling 3. Rating 4. Generating a cluster rating map 5. Validation of the cluster rating map The investigators will invite a representative sample of patients for study.
Other outcomes
Healthcare proffessionals' perspectives on determinants assessed by Group Concept Mapping
Following completion or in the final phase of the pilot study, the investigators will examine the perspectives of HCPs on important determinants of engagement in remote home blood monitoring using the Group Concept Mapping technique. The process will follow 5 pre-described steps and all activity will be online utilizing the software Groupwisdom. The steps are as follows: 1) Brainstorming 2) Sorting and labelling 3) Rating 4) Generating a cluster rating map 5) Validation of the cluster rating map The investigators will invite all participating intervention delivering HCP´s to the study.
Number of referrals
Number of referred patients
Recruitment rates
Number of enrolled vs. declined
Sex of enrolled patients
a) male; b) female
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Pomeranian Medical University Szczecin
Lead sponsor
University Clinical Centre, Gdansk
Collaborator
University Medicine Greifswald
Collaborator
University Medical Center Rostock
Collaborator
Zealand University Hospital
Collaborator