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

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.

Conditions

• Cancer
• Cancer-related Problem/Condition
• Chemotherapy
• Chemotherapy-induced Neutropenia
• Chemotherapy Induced Anaemia
• Chemotherapy Induced Thrombocytopenia

Sponsors & Collaborators

• University Clinical Centre, Gdansk

  collaborator OTHER

• University Medicine Greifswald

  collaborator OTHER

• University Medical Center Rostock

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Pomeranian Medical University Szczecin

  lead OTHER

Principal Investigators

• Bogusław Machaliński, MD, PhD, Prof · Department of Hematology and Transplantology, Pomeranian Medical University in Szczecin

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-17

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• Denmark
• Germany
• Poland

Study Locations