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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPomeranian Medical University Szczecin

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

legally competent patients

aged 18 or older

diagnosed with cancer (ICD-10: C00* - C97*)

enrolled at the Department of Oncology/Hematology for outpatients

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

265 Participants
are grouped into 2 trial groups
Group A: Study group
Group B: Control group

Trial outcomes

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.

Time frame
from 4 to 12 weeks of patient participation in the intervention

Secondary outcomes

Other outcomes

1

Healthcare proffessionals' 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 HCPs 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 all participating intervention delivering HCP´s to the study.

Time frame
between 5 patient treatments completed and end of study (on average 1 year)
2

Number of referrals

Number of referred patients

Time frame
Baseline
3

Recruitment rates

Number of enrolled vs. declined

Time frame
Baseline
4

Sex of enrolled patients

a) male; b) female

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pomeranian Medical University Szczecin

Lead sponsor

University Clinical Centre, Gdansk

Collaborator

University Medicine Greifswald

Collaborator

University Medical Center Rostock

Collaborator

Zealand University Hospital

Collaborator