Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas (SUPATEEN)

October 5, 2021 updated by: Julia Roick, Martin-Luther-Universität Halle-Wittenberg

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adolescents with leukemia, brain tumors, and sarcomas who are between 10 to 18 years old and their parents

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • having a relapse or secondary tumor
  • insufficient command of German
  • profound cognitive and physical impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children and adolescents with cancer
Children and adolescents between 10-18 years with newly diagnosed leukemia, brain tumors, and sarcomas
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within the first month after diagnosis until half a year after intensive treatment
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)
Within the first month after diagnosis until half a year after intensive treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the treatment
Time Frame: End of intensive 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
End of intensive treatment
Self-concept
Time Frame: Within the first month after diagnosis until half a year after intensive treatment
Self-Description Questionnaire, SDQ
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
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)
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
Social Support Scale, SSS Values: total score with a range 8-40 (higher values represent higher support)
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
Illness Perception Questionnaire, IPQ
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
General Self-Efficacy Scale; SWE
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
Subscale from The Bern Subjective Well-Being Questionnaire for Adolescents, BFW
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
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)
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
Children Sense of Coherence Scale, C-SOC
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
Coping Questionnaire for Children and Adolescents, CODI
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
Children's Depression Screener, Child-S
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
Subscale from The Kidscreen Questionnaire
Within the first month after diagnosis until half a year after intensive treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental coping with chronic childhood disease
Time Frame: Within the first month after diagnosis until half a year after intensive treatment
Coping Health Inventory for Parents, CHIP (parental questionnaire)
Within the first month after diagnosis until half a year after intensive treatment
Psychosocial needs
Time Frame: Within the first month after diagnosis until the end of intensive treatment
Short-Form Supportive Care Needs Survey Questionnaire, SCNS-SF34 (parental questionnaire)
Within the first month after diagnosis until the end of intensive treatment
Evaluation of the treatment
Time Frame: End of intensive treatment
Questionnaire to assess the Satisfaction with the Treatment, FBB
End of intensive treatment
Familial burden
Time Frame: End of intensive treatment until half a year after intensive treatment
Impact on Family Scale in Families with Children with Disabilities, FaBel (parental questionnaire)
End of intensive treatment until half a year after intensive treatment
Family resources
Time Frame: Within the first month after diagnosis and half a year after intensive treatment
Family Environment Scale, FES (parental questionnaire)
Within the first month after diagnosis and half a year after intensive treatment
Satisfaction with life
Time Frame: Within the first month after diagnosis until half a year after intensive treatment
The Satisfaction With Life Scale, SWL
Within the first month after diagnosis until half a year after intensive treatment
Doctor-parent relationship
Time Frame: End of intensive treatment
Patient Reactions Assessment, PRA-D
End of intensive treatment
Level of quality of life
Time Frame: Within the first month after diagnosis until half a year after intensive treatment
The Short Form Health Survey, SF-12
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
Sense of Coherence Scale - Leipziger Short Form, SOC-L9
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
Hospital Anxiety and Depression Scale, HADS
Within the first month after diagnosis until half a year after intensive treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Investigators

  • Study Chair: Matthias Richter, Prof. Dr., Martin-Luther-Universität Halle-Wittenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70113424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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