Clinical trial NCT03985215: The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives
Official title: The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Surveys and Questionnaires
Keywords: Aftercare
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Questionnaires will be sent to all the possible families in Denmark with a child in the period of 0-5 years after cessation of maintenance therapy for ALL.

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.

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.

Primary outcomes:
measure: Degree of parental concern
timeFrame: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
Secondary outcomes:
measure: Satisfaction with the follow-up program
timeFrame: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
measure: PedsQL scores
timeFrame: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
measure: The amount of self-reported side effects
timeFrame: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
measure: Strategy of the families between follow-up visits
timeFrame: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Karen Schow Jensen
state: Aarhus N
Study officials:
affiliation: Aarhus Universitet
name: Karen S Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References: