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

NCT ID: NCT03985215

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2021-11-30

Brief 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.

Detailed 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.

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Surveys and Questionnaires

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Questionnaires

Pediatric Quality of Life Inventory questionnaire. Self-designed questionnaire.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen S Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus Universitet

Locations

Karen Schow Jensen

Aarhus, Aarhus N, Denmark

Countries

Denmark

Other Identifiers

2016-051-000001

Identifier Type: -

Identifier Source: org_study_id