Precursor Cell Lymphoblastic Leukemia-LymphomaNCT03985215
The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives
An observational study of Precursor Cell Lymphoblastic Leukemia-Lymphoma and Surveys and Questionnaires, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Surveys and Questionnaires
- What is being tested?
- Questionnaires
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2020to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Questionnaires
- Keywords
- Aftercare
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Pediatric Quality of Life Inventory questionnaire. Self-designed questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of parental concern
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.
Measured: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
Secondary outcomes (4)
Satisfaction with the follow-up program
Self-designed questionnaire. An item evaluating satisfaction the time interval between visits on a scale 1-3. Higher values represent a worse outcome.
Measured: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
PedsQL scores
Pediatric Quality of Life Inventory questionnaire (the parent proxy). A validated measure of health-related quality of life.
Measured: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
The amount of self-reported side effects
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.
Measured: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
Strategy of the families between follow-up visits
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.
Measured: A single point in time when questionnaires are answered. The specific time point being 0-5 years after end of ALL treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study startDec 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: Overlapping with another danish questionnaire study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precursor Cell Lymphoblastic Leukemia-LymphomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen S Jensen, MD, Principal investigator, Aarhus Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985215
- Sponsor's protocol ID
- 2016-051-000001
- Status last verified
- Jul 2020
- First submitted
- 7 Jun 2019
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives
- ClinicalTrials.gov ID
- NCT03985215
- Acronym / sponsor ID
- 2016-051-000001
- Keywords
- Aftercare
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Overlapping with another danish questionnaire study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesPediatric Quality of Life Inventory questionnaire. Self-designed questionnaire. | Other | – |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen S Jensen, MD principal investigator
Aarhus Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Precursor Cell Lymphoblastic Leukemia-Lymphoma and Surveys and Questionnaires, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.