Primary Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia
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|ClinicalTrials.gov Identifier: NCT03985826|
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 18, 2019
Improved understanding of the long-time healthcare utilisation of childhood cancer survivors is relevant as it can be seen as a proxy for the population's morbidity.
The investigators will conduct a historic population-based matched cohort study using Danish nationwide registry data. Eligible children are children 1.0-17.9 years diagnosed with Acute lymphoblastic leukaemia (ALL) in Denmark from 1994 till 2016. The primary outcome is yearly contact rates to primary healthcare.
|Condition or disease||Intervention/treatment|
|Precursor Cell Lymphoblastic Leukemia-Lymphoma||Other: Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhood|
Acute lymphoblastic leukaemia (ALL) is the most frequent single form of cancer in children accounting for 40-45 new cases every year in Denmark. Over the past decades, advances in treatment have led to an increasing number of children who survive cancer and more than 80% of children with ALL now become long-term survivors. This means a growing population of childhood ALL survivors. In survivors, the cancer itself and treatment late-effects can lead to ongoing health care use.
Register studies of long-term survivors of childhood cancer have shown an increased risk of hospitalisation compared to the general population. It is mentioned in many of the studies that contact rates could be underestimated when looking at hospital contacts only.
The literature about non-hospital-based contacts with a doctor in childhood cancer survivors is scarce.
|Study Type :||Observational|
|Estimated Enrollment :||7700 participants|
|Official Title:||Primary Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia: A Population-Based Cohort Study|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||July 2021|
Childhood ALL survivors
The cohort of childhood ALL survivors will be identified in the Danish part of the Nordic Society of Paediatric Haematology and Oncology (NOPHO) ALL-Register .
Other: Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhood
The cohort of ALL survivors has all been diagnosed and treated for ALL in childhood
A reference cohort (comparison cohort) of individuals will be sampled randomly from the source population matched by age and sex and without a history of childhood cancer in the calendar year where the case was diagnosed (density sampling). For each childhood ALL-patient we will choose ten comparison subjects.
- The yearly contact rate to general practice for ALL survivors and controls [ Time Frame: 1-20 years follow-up ]Analysing longitudinal health care data with analysis of both first and recurrent events
- The monthly contact rate to general practice for ALL survivors [ Time Frame: 1-20 years follow-up ]Analysing longitudinal health care data with analysis of both first and recurrent events
- The total annual contact rate for primary and secondary healthcare for ALL survivors and controls [ Time Frame: 1-20 years follow-up ]Analysing longitudinal health care data with analysis of both first and recurrent events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985826
|Contact: Karen S Jensen, MD||0045 firstname.lastname@example.org|
|Study Director:||Peter Vedsted, Professor||Research Unit for General Practice, Institute for Public Health|