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Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia
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 |
| 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 : | September 1, 2019 |
| Actual Primary Completion Date : | November 30, 2019 |
| Actual Study Completion Date : | November 30, 2019 |
| Group/Cohort | 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 .
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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
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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.
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- 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 yearly contact rate to 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
| Ages Eligible for Study: | 1 Year to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
The study population will be identified in the Danish part of the Nordic Society of Paediatric Haematology and Oncology ALL database.
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.
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
| Denmark | |
| Department of Public Health | |
| Aarhus C, Denmark, 8000 | |
| Study Director: | Peter Vedsted, Professor | Research Unit for General Practice, Institute for Public Health |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 11, 2019 | ||||
| First Posted Date | June 14, 2019 | ||||
| Last Update Posted Date | December 3, 2020 | ||||
| Actual Study Start Date | September 1, 2019 | ||||
| Actual Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures |
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
|
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| Current Other Pre-specified Outcome Measures |
The yearly contact rate to 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
|
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| Original Other Pre-specified Outcome Measures |
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
|
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| Descriptive Information | |||||
| Brief Title | Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia | ||||
| Official Title | Health Care Utilisation Following Childhood Acute Lymphoblastic Leukaemia: A Matched Cohort Study | ||||
| 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. |
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| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population |
The study population will be identified in the Danish part of the Nordic Society of Paediatric Haematology and Oncology ALL database. 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. |
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| Condition | Precursor Cell Lymphoblastic Leukemia-Lymphoma | ||||
| Intervention | 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
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
7348 | ||||
| Original Estimated Enrollment |
7700 | ||||
| Actual Study Completion Date | November 30, 2019 | ||||
| Actual Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 1 Year to 18 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Denmark | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03985826 | ||||
| Other Study ID Numbers | ID277 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University of Aarhus | ||||
| Study Sponsor | University of Aarhus | ||||
| Collaborators | Research Unit for General Practice, Aarhus University | ||||
| Investigators |
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| PRS Account | University of Aarhus | ||||
| Verification Date | June 2019 | ||||
