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The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives

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ClinicalTrials.gov Identifier: NCT03985215
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment
Precursor Cell Lymphoblastic Leukemia-Lymphoma Surveys and Questionnaires Other: Questionnaires

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
Estimated Enrollment : 130 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 : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : June 2021



Intervention Details:
  • Other: Questionnaires
    Pediatric Quality of Life Inventory questionnaire. Self-designed questionnaire.


Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Satisfaction with the follow-up program [ 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. An item evaluating satisfaction the time interval between visits on a scale 1-3. Higher values represent a worse outcome.

  2. PedsQL scores [ Time Frame: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment. ]
    Pediatric Quality of Life Inventory questionnaire (the parent proxy). A validated measure of health-related quality of life.

  3. The amount of self-reported side effects [ 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. 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.


  4. Strategy of the families between follow-up visits [ 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. In need of advice between visits what are the strategy of the participants: seeking hospital, general practitioner or postponing till next scheduled visit.



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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Patients with B-precursor ALL and T-ALL enrolled in the NOPHO ALL-2008 trial
  • Age group 1.0-14.9 years.
  • Patients treated on one of the four Danish Paediatric oncology departments
  • Patients in the time period 0-5 years after cessation of maintenance therapy for ALL

Exclusion Criteria:

  • A history of recurrence or second malignancies
  • Bone marrow transplantation
  • Down syndrome
  • If, due to language barriers, the family is unable to complete the questionnaire.

Information from the National Library of Medicine

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): NCT03985215


Contacts
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Contact: Karen S Jensen, MD 0045 61718432 kascje@rm.dk
Contact: Peter Vedsted, Professor

Locations
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Denmark
Karen Schow Jensen Not yet recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Karen S Jensen, MD    0045 61718432    kascje@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Karen S Jensen, MD Aarhus Universitet

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03985215     History of Changes
Other Study ID Numbers: 2016-051-000001
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Aftercare

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases