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

NCT06809101 | Recruiting

• 2 other identifiers: p-2024-17504STHB.01.01-IP.01-0005/23
• Study Type: observational
• Target: 265
• Locations: 3 countries
• Sites: 5

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.

Conditions

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

Keywords

home blood monitoring; complete blood count; cancer; chemotherapy; implementation; research; e-health; oncology; home-based; feasibility

Outcome Measures

Primary Outcomes (1)

• Patient's perspectives on determinants assessed by Group Concept Mapping

  Following completion or in the final phase of the pilot study, the investigators will examine the perspectives of patients on important determinants of engagement in remote home blood monitoring using the Group Concept Mapping technique. The process will follow 5 pre-described steps and all activity will be online utilizing the software Groupwisdom. The steps are as follows: 1. Brainstorming 2. Sorting and labelling 3. Rating 4. Generating a cluster rating map 5. Validation of the cluster rating map The investigators will invite a representative sample of patients for study.

  from 4 to 12 weeks of patient participation in the intervention

Other Outcomes (28)

• Healthcare proffessionals' perspectives on determinants assessed by Group Concept Mapping

  between 5 patient treatments completed and end of study (on average 1 year)

• Number of referrals

  Baseline

• Recruitment rates

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients are patients that suffer from cancer, require outpatient chemotherapy, and have sufficient manual skills and good eyesight to independently perform home blood monitoring, and sufficient cognitive skills to operate POCT and transfer data.

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

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

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead
• University Clinical Centre, Gdansk: collaborator
• University Medicine Greifswald: collaborator
• University Medical Center Rostock: collaborator
• Zealand University Hospital: collaborator

Study Sites (5)

Department of Oncology, Zealand University Hospital

Næstved, Region Sjælland, 4700, Denmark

RECRUITING

Clinic and Polyclinic for Internal Medicine C, Hematology and Oncology, Palliative Care Unit, University Medical Center

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

RECRUITING

Department of Medicine, Clinic III, Hematology, Oncology, Palliative Medicine, University Medical Center

Rostock, Mecklenburg-Vorpommern, 18106, Germany

RECRUITING

Department of Oncology and Radiotherapy, University Clinical Center of Gdańsk,

Gdansk, Pomeranian Voivodeship, 80-952, Poland

RECRUITING

Department of Hematology and Transplantology

Szczecin, West Pomeranian Voivodeship, 71-252, Poland

RECRUITING

Related Links

• Homepage for the AMBeR project, of which the AMBeR Home Blood Monitoring is a work package and separately registered study.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Bogusław Machaliński, MD, PhD, Prof

  Department of Hematology and Transplantology, Pomeranian Medical University in Szczecin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bartłomiej Baumert, MD, PhD, DSc

CONTACT

+48 91 4250428; bartlomiej.baumert@pum.edu.pl

Karolina Szmuc, MSc

CONTACT

+48 91 4250428; karolina.szmuc@usk1.szczecin.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: February 5, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

DK (1); DE (2); PL (2)