The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives

Surveys and Questionnaires Clinical Trial

Official title:

The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03985215
• Other study ID #: 2016-051-000001
• Status: Withdrawn
• Start date: December 2020
• Est. completion date: November 2021

Study information

• Verified date: July 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Surveys and Questionnaires

Intervention

Other:
• Questionnaires
Pediatric Quality of Life Inventory questionnaire. Self-designed questionnaire.

Locations

Country	Name	City	State
Denmark	Karen Schow Jensen	Aarhus	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of parental concern	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.	A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
Secondary	Satisfaction with the follow-up program	Self-designed questionnaire. An item evaluating satisfaction the time interval between visits on a scale 1-3. Higher values represent a worse outcome.	A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
Secondary	PedsQL scores	Pediatric Quality of Life Inventory questionnaire (the parent proxy). A validated measure of health-related quality of life.	A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
Secondary	The amount of self-reported side effects	Self-designed questionnaire. Fifteen items scored on a scale 1-7. Higher values represent a worse outcome. An average is calculated over the fifteen items.; An item evaluating the duration of the time period before the child was able to attend day-care/school on a scale 1-5. Higher values represent a worse outcome.	A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
Secondary	Strategy of the families between follow-up visits	Self-designed questionnaire. In need of advice between visits what are the strategy of the participants: seeking hospital, general practitioner or postponing till next scheduled visit.	A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.