Actively Recruiting
Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Baltic Countries.
Led by Pomeranian Medical University Szczecin · Updated on 2026-02-27
265
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Pomeranian Medical University Szczecin
Lead Sponsor
U
University Clinical Centre, Gdansk
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cancer diagnoses are increasing yearly, requiring patients to have regular blood tests to ensure safety and eligibility for chemotherapy. Traveling to clinics for these tests can be burdensome, especially for those living far away, causing extra costs, reliance on helpers, risk of hospital infections, and missed treatments. This study aims to assess the successful implementation of remote home blood monitoring for cancer patients during and after systemic treatment, while also piloting new technology and evaluating costs and changes in patient care pathways. The study is conducted in three South Baltic countries (Denmark, Poland, and Germany) and includes two groups: a study group of 33 patients per center using home blood monitoring with the HemoScreen device, and a control group of 20 patients per center receiving standard blood tests at outpatient clinics. After training during the first chemotherapy cycle at the clinic, patients will perform blood tests at home for subsequent cycles, with results sent to coordinators before chemotherapy sessions. Decisions about chemotherapy administration are based on standard laboratory blood tests. The study covers four chemotherapy cycles and a three-month follow-up. Participants will complete questionnaires about health status, quality of life, and care experience at baseline, after treatment, and at follow-up. Researchers will monitor adherence to home testing, adverse events, and the potential reduction of unnecessary hospital visits. The study also involves workshops to support implementation and gathers patient and healthcare professional perspectives using Group Concept Mapping. Economic analyses will evaluate resource use and cost-effectiveness. Overall, the study lasts about 12 to 16 weeks of treatment plus 3 months follow-up for each participant.
CONDITIONS
Brief Title
Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Baltic Countries.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be legally competent.
- Aged 18 years or older.
- Diagnosed with cancer (ICD-10: C00* - C97*).
- Enrolled as outpatients at the Department of Oncology or Hematology.
- Willing and able to give informed consent.
- Receiving chemotherapy in a Daily Chemotherapy Unit within 4 weeks of treatment start.
- Expected chemotherapy duration of at least 12 weeks from inclusion.
You will not qualify if you...
- Unable to give informed consent due to mental capacity or language barrier.
- Unable or unlikely to perform fine manipulation needed for blood sampling with lancet or cartridge.
- Known bleeding disorder.
- Poor circulation preventing sufficient blood drops for testing.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 chemotherapy cycle (21 to 30 days)
Participants in the study group are trained to use the HemoScreen device and complete self-tests during their first chemotherapy cycle at the Outpatient Daily Clinic.
Visits during the first chemotherapy cycle at the Outpatient Daily Clinic
Duration - 3 chemotherapy cycles (approximately 9 to 12 weeks)
Participants use the HemoScreen device at home to monitor blood parameters before scheduled chemotherapy visits for up to 3 additional cycles.
Home testing prior to each chemotherapy visit during 3 cycles
Duration - 3 months after chemotherapy
Participants complete health status and quality of life questionnaires after 4 cycles of chemotherapy and again after a 3-month follow-up period to evaluate the impact of the intervention.
Questionnaire assessments at baseline, after 4 cycles, and after 3 months follow-up
Trial Site Locations
Total: 5 locations
1
Department of Oncology, Zealand University Hospital
Næstved, Region Sjælland, Denmark, 4700
Actively Recruiting
2
Clinic and Polyclinic for Internal Medicine C, Hematology and Oncology, Palliative Care Unit, University Medical Center
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Actively Recruiting
3
Department of Medicine, Clinic III, Hematology, Oncology, Palliative Medicine, University Medical Center
Rostock, Mecklenburg-Vorpommern, Germany, 18106
Actively Recruiting
4
Department of Oncology and Radiotherapy, University Clinical Center of Gdańsk,
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Actively Recruiting
5
Department of Hematology and Transplantology
Szczecin, West Pomeranian Voivodeship, Poland, 71-252
Actively Recruiting
Research Team
B
Bartłomiej Baumert, MD, PhD, DSc
K
Karolina Szmuc, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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