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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

265 Participants
are grouped into 2 trial groups

Locations

5
Denmark
Department of Oncology, Zealand University Hospital4700, NæstvedRegion Sjælland, Denmark
Germany
Clinic and Polyclinic for Internal Medicine C, Hematology and Oncology, Palliative Care Unit, University Medical Center17475, GreifswaldMecklenburg-Vorpommern, Germany
Department of Medicine, Clinic III, Hematology, Oncology, Palliative Medicine, University Medical Center18106, RostockMecklenburg-Vorpommern, Germany
Poland
Department of Oncology and Radiotherapy, University Clinical Center of Gdańsk,80-952, GdanskPomeranian Voivodeship, Poland

Sponsors and collaborators

Pomeranian Medical University Szczecin

Lead sponsor

University Clinical Centre, Gdansk

Collaborator

University Medicine Greifswald

Collaborator

University Medical Center Rostock

Collaborator

Zealand University Hospital

Collaborator