Condition or disease | Intervention/treatment |
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Precursor Cell Lymphoblastic Leukemia-Lymphoma Surveys and Questionnaires | Other: Questionnaires |
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.
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives |
Estimated Study Start Date : | December 2020 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | November 2021 |
Self-designed questionnaire. Six items scored on a scale 1-7. Higher values represent a worse outcome. An average is calculated over the six items.
An item evaluating the need for extra visits on a scale 1-3. Higher values represent a worse outcome.
An item evaluating parental reported worries about the future on a scale 1-5. Higher values represent a worse outcome.
Self-designed questionnaire. Fifteen items scored on a scale 1-7. Higher values represent a worse outcome. An average is calculated over the fifteen items.
An item evaluating the duration of the time period before the child was able to attend day-care/school on a scale 1-5. Higher values represent a worse outcome.
Tracking Information | |||||
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First Submitted Date | June 7, 2019 | ||||
First Posted Date | June 13, 2019 | ||||
Last Update Posted Date | September 7, 2020 | ||||
Estimated Study Start Date | December 2020 | ||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Degree of parental concern [ Time Frame: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment. ] Self-designed questionnaire. Six items scored on a scale 1-7. Higher values represent a worse outcome. An average is calculated over the six items.
An item evaluating the need for extra visits on a scale 1-3. Higher values represent a worse outcome.
An item evaluating parental reported worries about the future on a scale 1-5. Higher values represent a worse outcome.
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | 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 | ||||
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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. | ||||
Condition |
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Intervention | Other: Questionnaires
Pediatric Quality of Life Inventory questionnaire. Self-designed questionnaire.
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Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* 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 | Withdrawn | ||||
Actual Enrollment |
0 | ||||
Original Estimated Enrollment |
130 | ||||
Estimated Study Completion Date | November 2021 | ||||
Estimated Primary Completion Date | July 2021 (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 15 Years (Child) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Denmark | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03985215 | ||||
Other Study ID Numbers | 2016-051-000001 | ||||
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 | Not Provided | ||||
Investigators |
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PRS Account | University of Aarhus | ||||
Verification Date | July 2020 |