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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 : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date June 7, 2019
First Posted Date June 13, 2019
Last Update Posted Date September 9, 2019
Estimated Study Start Date October 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2019)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03985215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 12, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
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
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Surveys and Questionnaires
Intervention Other: Questionnaires
Pediatric Quality of Life Inventory questionnaire. Self-designed questionnaire.
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.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 12, 2019)
130
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Karen S Jensen, MD 0045 61718432 kascje@rm.dk
Contact: Peter Vedsted, Professor
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Aarhus
Study Sponsor University of Aarhus
Collaborators Not Provided
Investigators
Principal Investigator: Karen S Jensen, MD Aarhus Universitet
PRS Account University of Aarhus
Verification Date June 2019