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Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia

NCT ID: NCT03985826

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7348 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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 .

Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhood

Intervention Type OTHER

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.

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research Unit for General Practice, Aarhus University

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Vedsted, Professor

Role: STUDY_DIRECTOR

Research Unit for General Practice, Institute for Public Health

Locations

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Department of Public Health

Aarhus C, , Denmark

Site Status

Countries

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Denmark

References

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Jensen KS, Klug Albertsen B, Schroder H, Zalounina Falborg A, Schmiegelow K, Rosthoj S, Callesen MT, Vedsted P. Health care utilisation following childhood acute lymphoblastic leukaemia: a population-based matched cohort study. BMJ Open. 2021 Nov 22;11(11):e049847. doi: 10.1136/bmjopen-2021-049847.

Reference Type DERIVED
PMID: 34810184 (View on PubMed)

Other Identifiers

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ID277

Identifier Type: -

Identifier Source: org_study_id