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

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Department of Oncology, Zealand University Hospital
RECRUITING
Næstved
Germany
Clinic and Polyclinic for Internal Medicine C, Hematology and Oncology, Palliative Care Unit, University Medical Center
RECRUITING
Greifswald
Department of Medicine, Clinic III, Hematology, Oncology, Palliative Medicine, University Medical Center
RECRUITING
Rostock
Poland
Department of Oncology and Radiotherapy, University Clinical Center of Gdańsk,
RECRUITING
Gdansk
Department of Hematology and Transplantology
RECRUITING
Szczecin
Contact Information
Primary
Bartłomiej Baumert, MD, PhD, DSc
bartlomiej.baumert@pum.edu.pl
+48 91 4250428
Backup
Karolina Szmuc, MSc
karolina.szmuc@usk1.szczecin.pl
+48 91 4250428
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 265
Treatments
Study group
Oncology patients undergoing home blood monitoring. n=33 per site.
Control group
Oncology patients undergoing standard blood testing in the general laboratory at the Outpatient Clinic.~n=20 per site.
Related Therapeutic Areas
Sponsors
Leads: Pomeranian Medical University Szczecin
Collaborators: University Clinical Centre, Gdansk, Zealand University Hospital, University Medicine Greifswald, University Medical Center Rostock

This content was sourced from clinicaltrials.gov

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