The Potential of HemoScreen for Monitoring Blood Values in Cancer Patients at Home

NCT04543734 | Completed

• 1 other identifier: Hem2020
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To keep cancer patients safe, whilst in chemo therapy, patients come into the hospital for multiple blood tests, in order to provide safe antineoplastic treatment and supportive care. Monitoring of relevant blood values (WBC white blood cell count, total and differentiated, ANC absolute neutrophil count, RBC red blood cell count, HGB hemoglobin and PLT platelets) is usually obtained by venipuncture by a health-care professional at the hospital. HemoScreen is a POCT (point-of-care-technology) automated hematology analyzer that performs complete blood count (CBC) analysis from capillary or venous whole-blood samples. HemoScreen solution has not yet been used by patients to self-test blood cell count, but the investigators hypothesize that cancer patients on systemic anticancer therapy can perform a self-test at home using HemoScreen, and transfer the results to the hospital clinical team, to prevent wasted hospital journeys. This study aims to investigate the feasibility and usability of HemoScreen hematology analyzer for capillary self-testing of blood values in home for cancer patients receiving chemo. The study consists of a quantitative and a qualitative part. The quantitative part is to compare blood values obtained by capillary self-testing using HemoScreen and venous blood values obtained on standard hospital equipment (Sysmex) in patients. The qualitative part will be observational studies and semi-structured interviews with patients as well as health professionals from the department of Clinical Oncology, as they perform a capillary blood test with HemoScreen themselves. Recruitment of participants will take place at the department of Clinical Oncology in Naestved. This present study has two phases. The first phase (1) will investigate feasibility, usability and measurement properties of the HemoScreen CBC analyzer, when patients perform a capillary self-test in the outpatient clinic at Oncology supervised by trained personal. Furthermore, Healthcare professionals will test the capillary blood count method. Phase 1 will be conducted to insure that HemoScreen is safely used for capillary self-testing by patient before initiating phase 2, where the HemoScreen is being sent home with the patients for self-measure at home. In Phase 1, 10 cancer patients as well as 4-10 health professionals will be recruited. In phase 2, 33 cancer patients initiating a chemotherapy treatment will be recruited for testing in their home.

Conditions

Cancer

Keywords

Cancer; Complete blood count; Point-of-care; HemoScreen

Outcome Measures

Primary Outcomes (6)

• The usability of PixCell HemoScreen for self-testing by cancer patients receiving chemo.

  In phase 1 (ambulatory) and 2 (ambulatory and home): The patients will be observed when they perform self-testing in the ambulatory. The observer records in what order the different steps are conducted, and whether the different steps are performed correctly. The capability of each participant to perform self-testing will be evaluated. An overall capability score between 1-10 (1 low and 10 high performance) will be reported. The observation should identify the specific challenges in self-testing with HemoScreen and potential difficulties for the specific patient group. These observations will be reported. Furthermore, the patients will be interviewed about how they perceive their own performance at self-testing. In phase 2, a semistructured interview will be conducted in patients home to investigate how the patients experience self-testing with HemoScreen at home. Based on observations and qualitative date the usability of HemoScreen in home will be evaluated and reported.

  16 weeks

• Accuracy of capillary blood counts in self-testing with HemoScreen. Comparison of capillary self-test blood counts versus venous blood counts.

  Comparison of capillary and venous blood counts will be performed to investigate the applicability of the capillary self-test performed by the patient. In phase 1 and 2 the patients will perform a capillary self-test with HemoScreen in ambulatory. Furthermore, a venous blood sample from the patient (drawn by nurse) will be analyzed at the Sysmex 9000 (standard procedure) and HemoScreen by nurse. In phase 2, further (approximately 5-6) capillary self-tests will be conducted by patients in patients own home. On the same day of capillary self-testing in home the patients will go to the hospital to have a venous blood sample drawn. The venous blood sample will be analyzed at Sysmex 9000 (standard procedure). Hematological components specified as measure 3, 4, 5 and 6 will be statistically compared with two sampled paired t-test, Deming regression and Pearson's correlation coefficient.

  16 weeks

• WBC (White blood cell) count

  The total count of the white blood cells as well as differentiated count of white blood cells will be measured on HemoScreen as well as Sysmex 9000. The differentiated counts includes: Neutrophilocytes (10\^9/L ) Lymphocytes (10\^9/L ) Monocytes (10\^9/L ) Eosinophilocytes (10\^9/L ) Basophilocytes (10\^9/L ) Deming regression, CV%, STD will be calculated to ensure the reliability of the results. The results will be evaluated specific to the lower range.

  16 weeks

• RBC (Red blood cell) count

  The count of the red blood cells will be measured on HemoScreen as well as Sysmex 9000. The red blood cells is measured in unit: 10\^9/L Deming regression, CV%, STD will be calculated to ensure the reliability of the results. The results will be evaluated specific to the lower range.

  16 weeks

• HGB (Hemoglobin)

  Hemoglobin will be measured on HemoScreen as well as Sysmex 9000. Hemoglobin is measured in unit: mmol/L Deming regression, CV%, STD will be calculated to ensure the reliability of the results. The results will be evaluated specific to the lower range.

  16 weeks

• PLT (Platelets) count

  The count of platelets will be analyzed on HemoScreen and Sysmex 9000. Platelets is measured in unit: 10\^9/L Deming regression, CV%, STD will be calculated to ensure the reliability of the results. The results will be evaluated specific to the lower range.

  16 weeks

Interventions

HemoScreen hematology analyzer DEVICE

The use of HemoScreen for self-testing of blood values

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The main study population will be patients diagnosed with breast cancer receiving anti-cancer treatment at the department of Oncology for outpatients. 10 patients in the first phase, testing the HemoScreen at the outpatient clinic only once, and 33 patients in the second phase testing in the outpatient clinic once as well as conducting self-testing at home during their anti-cancer treatment. A minor group of Health-care professionals from the Department of Oncology(between 5-10) will test the HemoScreen once in the ambulatory in the first phase.

You may qualify if:

• Breast cancer patients receiving anti-cancer treatment at the Department of Oncology for outpatients
• years old or more

You may not qualify if:

• Patients unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and results
• Known bleeding disorders
• Bad circulation, if the patient cannot get enough blood drops to do the test
• Inability to give informed content due to mental capacity or language barrier
• Working at the Department of Oncology for outpatients
• years old or more
• If 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 disorders
• Bad circulation, if the testperson cannot get enough blood drops to do the test
• Inability to give informed content

Sponsors & Collaborators

• Niels Henrik Holländer: lead

Study Sites (1)

Zealand University Hospital, Oncology

Næstved, 4700, Denmark

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Niels Henrik Holländer, MD

  Zealand University hospital, Næstved

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician, MD

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 10, 2020
• Study Start: September 11, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

DK (1)