LeukemiaSUPATEENNCT04101123
Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas
An observational study of Leukemia and Brain Tumor, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
Aim of this study is to investigate the influence of social factors on participation and activity among children and adolescents aged 10-18 years with leukemia, brain tumors, and sarcomas. Furthermore personal and treatment-related factors and their impact on participation will be explored Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Leukemia, Brain Tumor, Sarcoma
- What is being tested?
- Non-Interventional
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to 31 Dec 2023
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents with leukemia, brain tumors, and sarcomas who are between 10 to 18 years old and their parents
Who may be able to join
- newly diagnosed with confirmed leukemia, brain tumor or sarcoma
- age 10-18 years
- written informed consent of the patient and of one of the parents if they are under the age of 18
Who cannot join
- having a relapse or secondary tumor
- insufficient command of German
- profound cognitive and physical impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social Inequalities in the Participation and Activity in Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas
Aim of this study is to investigate the influence of social factors on participation and activity among children and adolescents aged 10-18 years with leukemia, brain tumors, and sarcomas. Furthermore personal and treatment-related factors and their impact on participation will be explored
Read the detailed description
Background: About 2000 children and adolescents under the age of 18 develop cancer each year in Germany. Because of more differentiated diagnostics and standardized treatment protocols, a high survival rate can be reached for many types of the disease. Nevertheless, patients face a number of long-term effects related to the treatment. As a result, physical and psychological consequences have increasingly become the focus of research in recent years. Social dimensions of health have rarely been investigated in pediatric oncology so far. Yet, there are no robust results that allow an estimation of whether and to what extent the disease and treatment impair the participation of children and adolescents and which factors mediate this effect. Social participation is of great importance especially because interactions with peers and experiences in different areas of life are essential for the development of children and adolescents.
Methods: Data are collected in a longitudinal, prospective, observational multicenter study. For this purpose, all patients and their parents who are being treated for cancer in one of the participating clinics throughout Germany will be interviewed within the first month after diagnosis (t1), after completion of intensive treatment (t2) and half a year after the end of intensive treatment (t3) using standardized questionnaires. Analysis will be done by descriptive and multivariate methods.
Recruitment: Patients will be consecutively recruited in one of the participating clinics throughout Germany.
- Conditions
- Leukemia, Brain Tumor, Sarcoma, Childhood Cancer, Cancer, Adolescent Cancer
- Being tested
- Non-Interventional
- Keywords
- Social inequalities, Social dimensions of health, Brain tumors, Leukemia, Sarcomas, Childhood Cancer, Children and adolescents with cancer
- Medical subject headings
- Leukemia, Brain Neoplasms, Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents with cancer | Children and adolescents between 10-18 years with newly diagnosed leukemia, brain tumors, and sarcomas Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social participation and activity
The Child and Adolescent Scale of Participation, CASP
Measured: Within the first month after diagnosis until half a year after intensive treatment
Level of quality of life
Questionnaire to assess Health Related Quality of Life in chronically ill Children and Adolescents, KINDL Subscales: physical well-being, emotional well-being, self-esteem, family, friends, school, and a total score Values: range from 0 to 100 (higher values represent better quality of life)
Measured: Within the first month after diagnosis until half a year after intensive treatment
Secondary outcomes (12)
Evaluation of the treatment
Questionnaire to assess the Satisfaction with the Treatment, FBB Subscales: success of treatment (range 0-20), relationship to medical team (range 0-28), treatment conditions (range 0-24), and a total score (range 0-72) Values: higher values represent better evaluation
Measured: End of intensive treatment
Self-concept
Self-Description Questionnaire, SDQ
Measured: Within the first month after diagnosis until half a year after intensive treatment
Fatigue
Subscale Fatigue from the Questionnaire to assess Quality of Life of Cancer Patients developed by the European Organisation for Research and Treatment of Cancer, EORTC QLQ-C30 Values: range from 0 to 100 (higher values represent higher symptoms of fatigue)
Measured: Within the first month after diagnosis until half a year after intensive treatment
Social support
Social Support Scale, SSS Values: total score with a range 8-40 (higher values represent higher support)
Measured: Within the first month after diagnosis until half a year after intensive treatment
Illness perception
Illness Perception Questionnaire, IPQ
Measured: Within the first month after diagnosis until half a year after intensive treatment
Self-efficacy
General Self-Efficacy Scale; SWE
Measured: Within the first month after diagnosis until half a year after intensive treatment
Optimism
Subscale from The Bern Subjective Well-Being Questionnaire for Adolescents, BFW
Measured: Within the first month after diagnosis until half a year after intensive treatment
Psychosocial problems and strengths
Strengths and Difficulties Questionnaire, SDQ Subscales: emotional problems, conduct problems, peer problems, hyperactivity, and prosocial behavior Values: each scale has a range 0-10 (higher values represent higher problems except prosocial behavior)
Measured: Within the first month after diagnosis until half a year after intensive treatment
Sense of coherence
Children Sense of Coherence Scale, C-SOC
Measured: Within the first month after diagnosis until half a year after intensive treatment
Coping
Coping Questionnaire for Children and Adolescents, CODI
Measured: Within the first month after diagnosis until half a year after intensive treatment
Mental health
Children's Depression Screener, Child-S
Measured: Within the first month after diagnosis until half a year after intensive treatment
Autonomy
Subscale from The Kidscreen Questionnaire
Measured: Within the first month after diagnosis until half a year after intensive treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Jan 2020
- Primary completion1 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Roick, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Matthias Richter, Prof. Dr., Study chair, Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101123
- Sponsor's protocol ID
- 70113424
- Acronym
- SUPATEEN
- Status last verified
- Jun 2024
- First submitted
- 23 Sep 2019
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roick J, Berner R, Bernig T, Erdlenbruch B, Escherich G, Faber J, Klein C, Bochennek K, Kratz C, Kuhr J, Langler A, Lode HN, Metzler M, Muller H, Reinhardt D, Sauerbrey A, Schepper F, Scheurlen W, Schneider D, Schwabe GC, Richter M. Social inequalities in the participation and activity of children and adolescents with leukemia, brain tumors, and sarcomas (SUPATEEN): a protocol for a multicenter longitudinal prospective observational study. BMC Pediatr. 2020 Jan 31;20(1):48. doi: 10.1186/s12887-020-1943-3.
PubMed 32005112
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Inequalities in the Participation and Activity in Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas
- ClinicalTrials.gov ID
- NCT04101123
- Acronym / sponsor ID
- SUPATEEN / 70113424
- Conditions
- Leukemia, Brain Tumor, Sarcoma, Childhood Cancer, Cancer, Adolescent Cancer
- Keywords
- Social inequalities, Social dimensions of health, Brain tumors, Leukemia, Sarcomas, Childhood Cancer, Children and adolescents with cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Sep 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.
Aim of this study is to investigate the influence of social factors on participation and activity among children and adolescents aged 10-18 years with leukemia, brain tumors, and sarcomas. Furthermore personal and treatment-related factors and their impact on participation will be explored
Detailed description
Background: About 2000 children and adolescents under the age of 18 develop cancer each year in Germany. Because of more differentiated diagnostics and standardized treatment protocols, a high survival rate can be reached for many types of the disease. Nevertheless, patients face a number of long-term effects related to the treatment. As a result, physical and psychological consequences have increasingly become the focus of research in recent years. Social dimensions of health have rarely been investigated in pediatric oncology so far. Yet, there are no robust results that allow an estimation of whether and to what extent the disease and treatment impair the participation of children and adolescents and which factors mediate this effect. Social participation is of great importance especially because interactions with peers and experiences in different areas of life are essential for the development of children and adolescents.
Methods: Data are collected in a longitudinal, prospective, observational multicenter study. For this purpose, all patients and their parents who are being treated for cancer in one of the participating clinics throughout Germany will be interviewed within the first month after diagnosis (t1), after completion of intensive treatment (t2) and half a year after the end of intensive treatment (t3) using standardized questionnaires. Analysis will be done by descriptive and multivariate methods.
Recruitment: Patients will be consecutively recruited in one of the participating clinics throughout Germany.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents with cancer | – | Other: Non-InterventionalChildren and adolescents between 10-18 years with newly diagnosed leukemia, brain tumors, and sarcomas |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents with leukemia, brain tumors, and sarcomas who are between 10 to 18 years old and their parents
Key inclusion criteria (3 listed)
- newly diagnosed with confirmed leukemia, brain tumor or sarcoma
- age 10-18 years
- written informed consent of the patient and of one of the parents if they are under the age of 18
Key exclusion criteria (3 listed)
- having a relapse or secondary tumor
- insufficient command of German
- profound cognitive and physical impairments
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 |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Children and adolescents with cancer |
Primary outcome
Social participation and activity
Time frame: Within the first month after diagnosis until half a year after intensive treatment
The Child and Adolescent Scale of Participation, CASP
Level of quality of life
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Questionnaire to assess Health Related Quality of Life in chronically ill Children and Adolescents, KINDL Subscales: physical well-being, emotional well-being, self-esteem, family, friends, school, and a total score Values: range from 0 to 100 (higher values represent better quality of life)
12 secondary outcomes
Evaluation of the treatment
Time frame: End of intensive treatment
Self-concept
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Fatigue
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Social support
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Illness perception
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Self-efficacy
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Optimism
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Psychosocial problems and strengths
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Sense of coherence
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Coping
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Mental health
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Autonomy
Time frame: Within the first month after diagnosis until half a year after intensive treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 32005112Roick J, Berner R, Bernig T, Erdlenbruch B, Escherich G, Faber J, Klein C, Bochennek K, Kratz C, Kuhr J, Langler A, Lode HN, Metzler M, Muller H, Reinhardt D, Sauerbrey A, Schepper F, Scheurlen W, Schneider D, Schwabe GC, Richter M. Social inequalities in the participation and activity of children and adolescents with leukemia, brain tumors, and sarcomas (SUPATEEN): a protocol for a multicenter longitudinal prospective observational study. BMC Pediatr. 2020 Jan 31;20(1):48. doi: 10.1186/s12887-020-1943-3.
- 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.
Matthias Richter, Prof. Dr. study chair
Martin-Luther-Universität Halle-Wittenberg
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 Leukemia and Brain Tumor, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jun 2024. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Social participation and activity (time frame: Within the first month after diagnosis until half a year after intensive treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04101123, which also lists 1 linked publication.
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 27 Jun 2024.