NCT06809101 Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Baltic Countries.
| NCT ID | NCT06809101 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pomeranian Medical University Szczecin |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 265 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 265 participants in total. It began in 2025-03-17 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Bogusław Machaliński, MD, PhD, Prof
PRINCIPAL INVESTIGATOR
Department of Hematology and Transplantology, Pomeranian Medical University in Szczecin
Frequently Asked Questions
Who can join the NCT06809101 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06809101 currently recruiting?
Yes, NCT06809101 is actively recruiting participants. Contact the research team at bartlomiej.baumert@pum.edu.pl for enrollment information.
Where is the NCT06809101 trial being conducted?
This trial is being conducted at Næstved, Denmark, Greifswald, Germany, Rostock, Germany, Gdansk, Poland and 1 additional location.
Who is sponsoring the NCT06809101 clinical trial?
NCT06809101 is sponsored by Pomeranian Medical University Szczecin. The principal investigator is Bogusław Machaliński, MD, PhD, Prof at Department of Hematology and Transplantology, Pomeranian Medical University in Szczecin. The trial plans to enroll 265 participants.
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