Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Baltic Countries.

Recruiting now

Conditions studied: Cancer, Cancer-related Problem/Condition, Chemotherapy, Chemotherapy-induced Neutropenia, Chemotherapy Induced Anaemia, Chemotherapy Induced Thrombocytopenia

In brief

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.

Key facts

Study ID: NCT06809101
Run by: Pomeranian Medical University Szczecin
People needed: 265
Starts: 2025-03-17
Expected to finish: 2027-03-31
Last updated by the study team: 2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

legally competent patients
aged 18 or older
diagnosed with cancer (ICD-10: C00* - C97*)
enrolled at the Department of Oncology/Hematology for outpatients
participants who are willing and able to give informed consent for participation in the study
participants should receive chemotherapy in Daily Chemotherapy Unit and be within 4 weeks of chemotherapy initiation, and the expected duration of chemotherapy should be at least 12 weeks from inclusion

You may not qualify if…

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

Where it is running

Department of Oncology, Zealand University Hospital — Næstved, Region Sjælland, Denmark (enrolling)
Clinic and Polyclinic for Internal Medicine C, Hematology and Oncology, Palliative Care Unit, University Medical Center — Greifswald, Mecklenburg-Vorpommern, Germany (enrolling)
Department of Medicine, Clinic III, Hematology, Oncology, Palliative Medicine, University Medical Center — Rostock, Mecklenburg-Vorpommern, Germany (enrolling)
Department of Oncology and Radiotherapy, University Clinical Center of Gdańsk, — Gdansk, Pomeranian Voivodeship, Poland (enrolling)
Department of Hematology and Transplantology — Szczecin, West Pomeranian Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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