A National Danish Proof of Concept on Feasiblity and Safety of Home-based Intensive Chemotherapy in Patients With Acute Leukemia.

Rigshospitalet, Denmark9 个研究点分布在 1 个国家目标入组 104 人开始时间: 2017年1月最近更新: 2021年5月27日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Rigshospitalet, Denmark
入组人数: 104
试验地点: 9
主要终点: Number of days home during treatment

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

a multicenter single-arm feasibility and safety study of home-based intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia and their quality of life and psychological wellbeing. This national study included patients from six sites in Denmark who received intensive chemotherapy on programmed CADD Solis infusion pumps through a central venous catheter and were also managed as outpatients during treatment-induced pancytopenia.

详细描述

This national single-arm feasibility cohort study was conducted at six hematology departments at six university hospitals in Denmark: Copenhagen University Hospital, Rigshospitalet; Herlev/Gentofte Hospital; Zealand University Hospital, Roskilde; Odense University Hospital; Aarhus University Hospital, and Aalborg University Hospital.

The project nurse at each site approached and recruited participants from October 2017 to August 2020. The participants were explicitly evaluated for their ability to manage their symptoms, administer oral medication, eat and drink sufficiently, and practice good personal hygiene. Eligible participants received oral and written information and provided written informed consent before inclusion.

Included participants received intensive chemotherapy treatment on a CADD pump through their CVC. The CADD pump is unique because it is portable, carried in a small bag or backpack, and applicable for home-based treatment due to its intuitive and user-friendly interface.

A patient educational program based on strategic patient involvement was integrated into supportive care practice during induction treatment at each hematology department. The program included guidance and training to the patient and/or their primary caregiver in managing the care of their CVC including drawing blood samples, how to use a positive expiratory pressure whistle, functionality of the infusion pump, how to manage and react on pump alarm, and precautions when receiving treatment while being home.

The participants could contact the hematological department from where they received their treatment 24 hours a day by telephone. They were instructed to contact their respective department immediately if fever (>38.0 Celcius) or any pump report alarm occurred. The nurses would then guide the participant to solve the problem from home or recommend they seek help at the department to solve the problem or get evaluated by a doctor.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Supportive Care
盲法: None

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

•Participants 18 years or older were included within the first 28 days from diagnosis with AML or high-risk MDS if intensive chemotherapy treatment was planned.

排除标准

•Patients were excluded if they did not understand, read and speak Danish, suffered from a severe illness requiring hospitalization if they had an unstable medical disease or any cognitive/psychiatric disorders. During the intervention, participants were withdrawn if hospitalized in an intensive care unit for more than two weeks, if they had a psychological condition (delirium or severe depression), or in case of transition to terminal care or if deceased. Moreover, participants were censored if they relapsed or transitioned to hematopoietic stem cell transplantation (HSCT).