The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Degree of parental concern
研究概览
简要总结
The aim of the study is to evaluate the family perspective on follow-up programs after treatment for childhood acute lymphoblastic leukaemia. It is relevant when new follow-up programs are to be designed.
详细描述
More than 90 % of paediatric patients with acute lymphoblastic leukaemia (ALL), treated on the Nordic Society of Pediatric Hematology and Oncology (NOPHO) ALL-2008 protocol, are alive five years after diagnosis. The main reason for treatment failure being relapse.
The risk of relapse after treatment for ALL is highest within the first two years after cessation of maintenance therapy. Therefore, it has been routine in most countries to follow-up patients in the outpatient clinic every one or two months during the first years after end of therapy for ALL in order to detect recurrence and possible late sequelae at an early stage.
In children with ALL there are only a few studies on the value of routine follow-up, including haematological status after cessation of maintenance therapy. These studies showed that approximately 90% of the relapses were diagnosed in children with symptoms of leukaemia progression and that routine blood tests and clinical follow-ups were of little value. It is well known that there are other issues besides the risk of relapse, which are relevant for families after cessation of ALL therapy i.e. risk of late effects of treatment, psychosocial problems related to the child's return to "normal" life etc. These issues will also have an impact upon how the follow-up programs are planned. The investigators will study the family perspectives on follow-up during the first 5-years after cessation of maintenance therapy in a Danish cohort of children treated according to the NOPHO ALL-2008 protocol.
The investigators will conduct a cross-sectional study. Outcomes are patient-reported as the measurement instrument used is questionnaires. Eligible families are families with children diagnosed with acute lymphoblastic leukaemia in Denmark and being in the period 0-5 years after cessation of maintenance therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with B-precursor ALL and T-ALL enrolled in the NOPHO ALL-2008 trial
- •Age group 1.0-14.9 years.
- •Patients treated on one of the four Danish Paediatric oncology departments
- •Patients in the time period 0-5 years after cessation of maintenance therapy for ALL
排除标准
- •A history of recurrence or second malignancies
- •Bone marrow transplantation
- •Down syndrome
- •If, due to language barriers, the family is unable to complete the questionnaire.
结局指标
主要结局
Degree of parental concern
时间窗: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
Self-designed questionnaire. Six items scored on a scale 1-7. Higher values represent a worse outcome. An average is calculated over the six items. An item evaluating the need for extra visits on a scale 1-3. Higher values represent a worse outcome. An item evaluating parental reported worries about the future on a scale 1-5. Higher values represent a worse outcome.
次要结局
- Satisfaction with the follow-up program(A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.)
- PedsQL scores(A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.)
- The amount of self-reported side effects(A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.)
- Strategy of the families between follow-up visits(A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.)