Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Baltic Countries.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 265
- 试验地点
- 5
- 主要终点
- Patient's perspectives on determinants assessed by Group Concept Mapping
研究概览
简要总结
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.
详细描述
Introduction:
The incidence of cancer is expected to increase by 30% over the next 20 years, mainly due to the increase in the elderly population. This will lead to a dramatic increase in the number of cancer patients in the future. 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 or modified. 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. Digitizing cancer care can increase patients' active involvement in their own treatment, improve quality of life and reduce inequalities in access to health care. Therefore, there is a strong need to develop and implement new ways of making cancer diagnostics and treatments available to patients in their own homes.
Objective 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 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.
Methods
Trial design This study is a multinational multisite implementation research study to pilot test implementation of home blood monitoring in 3 South Baltic countries (PL, DK, GER).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •participants should receive chemotherapy in Daily Chemotherapy Unit and be within 4 weeks of chemotherapy initiation, and the expected duration of chemotherapy should be at least 12 weeks from inclusion
排除标准
- •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
结局指标
主要结局
Patient's perspectives on determinants assessed by Group Concept Mapping
时间窗: from 4 to 12 weeks of patient participation in the intervention
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.
次要结局
未报告次要终点