Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06809101 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: AMBeR eBlood
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion dates: Jul 30, 2026 to Mar 31, 2027v7
  2. Minor Site details revised at 1 of 5 sitesv6
  3. Minor Site details revised at 1 of 5 sitesv5
  4. Minor Site details revised at 1 of 5 sitesv4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 15, 2025 to Mar 17, 2025
    • Site details revised at 5 of 5 sites
    v3
  6. Notable Primary endpoint revised
    • Start date: Jan 31, 2025 to Feb 15, 2025
    • Study description shortened, about 144 words
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06809101
Lead Sponsor Pomeranian Medical University Szczecin
Collaborators: University Clinical Centre, Gdansk, University Medicine Greifswald, University Medical Center Rostock, Zealand University Hospital
Conditions
(from sponsor)
Cancer, Cancer-related Problem/Condition, Chemotherapy, Chemotherapy-induced Neutropenia, Chemotherapy Induced Anaemia, Chemotherapy Induced Thrombocytopenia
Related terms Neoplasms
Enrollment 265 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov