Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT03985826
Collaborator
Research Unit for General Practice, Aarhus University (Other)
7,348
1
3
2485.1

Study Details

Study Description

Brief Summary

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 Phase
  • Other: Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhood

Detailed Description

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 Design

Study Type:
Observational
Actual Enrollment :
7348 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Health Care Utilisation Following Childhood Acute Lymphoblastic Leukaemia: A Matched Cohort Study
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Nov 30, 2019
Actual Study Completion Date :
Nov 30, 2019

Arms and Interventions

Arm Intervention/Treatment
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

Comparison cohort

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.

Outcome Measures

Primary Outcome Measures

  1. The yearly contact rate to general practice for ALL survivors and controls [1-20 years follow-up]

    Analysing longitudinal health care data with analysis of both first and recurrent events

Other Outcome Measures

  1. The yearly contact rate to secondary healthcare for ALL survivors and controls [1-20 years follow-up]

    Analysing longitudinal health care data with analysis of both first and recurrent events

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • B-precursor ALL and T-ALL enrolled in the NOPHO ALL-92, ALL-2000 and ALL-2008 trials.

  • Treated at one of the four Danish paediatric oncology departments

  • Age group 1.0-14.9 for the NOPHO ALL-92 and ALL-2000 trials. Age group 1.0-17.9 for the NOPHO ALL-2008 trial.

  • Completed maintenance therapy in the time period form 01.01.1997 till 31.12.2016

Exclusion Criteria:
  • Children with Down syndrome

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Public Health Aarhus C Denmark 8000

Sponsors and Collaborators

  • University of Aarhus
  • Research Unit for General Practice, Aarhus University

Investigators

  • Study Director: Peter Vedsted, Professor, Research Unit for General Practice, Institute for Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT03985826
Other Study ID Numbers:
  • ID277
First Posted:
Jun 14, 2019
Last Update Posted:
Dec 3, 2020
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2020