Web based mobile application for titrating maintenance therapy in children with acute lymphoblastic leukemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- To determine the feasibility of using a web-based application for monitoring maintenance therapy in
研究概览
简要总结
The treatment of Acute Lymphoblastic Leukemia (ALL) in children lasts for 2–2.5 years, which consists of an initial 6–7 months of intensive therapy consisting of injections and oral chemotherapy, followed by 2 years of a maintenance phase, which usually consists of oral chemotherapy in the form of daily administration of oral tablets. Most of the maintenance therapy is administered at home, allowing the child to return to normal life, including school and regular activities. Children have regular blood tests to monitor their blood counts and the effect of the medication. The chemotherapy doses are then adjusted based on these results to maintain appropriate blood counts. Our study explores the feasibility of using a web-based mobile application to review the blood tests done by the children at their home and subsequently guide the dosing of medication. We are also looking at the quality of life experienced by the children once the child goes back to their home and rejoins school. We are looking forward to enrolling about 1000 patients through our mobile application service, who would be included in our study. Through this study, we look forward to streamlining and standardising the phase of maintenance therapy in the treatment of acute leukemia and identifying factors responsible for the decrease in compliance and adherence to treatment, as well as the low quality of life experienced by the children and their parents once they return home.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All patients with acute lymphoblastic leukemia/Lymphoma less than 15 years of age at the time of registration.
- •A parent/caretaker who understands the basic functioning of internet and committed enough to follow dose adjustment as communicated.
- •Written informed consent according to institutional guidelines.
排除标准
- •Unwillingness to participate in the study.
结局指标
主要结局
To determine the feasibility of using a web-based application for monitoring maintenance therapy in
时间窗: The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval.
patients with newly diagnosed acute lymphoblastic leukemia/lymphoma.
时间窗: The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval.
次要结局
- To assess the Health Related- Quality Of Life (HR-QOL) in children on maintenance therapy(The web application will be introduced to the patients after initiation of the maintenance therapy.)
- To assess compliance to maintenance therapy in children with acute lymphoblastic(leukemia/lymphoma.)
- To assess adherence of medications during maintenance therapy(The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval.)
- Explore impact of dose intensity of maintenance therapy(The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval.)
- To study the social impact of maintenance therapy on patient and families(The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval.)
研究者
Dr Chetan Dhamne
Tata Memorial Hospital