Skip to main content
OpenTrials
Completed

NCT Number: NCT04101123

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leukemia Adolescent Cancer Brain Diseases Brain Neoplasms Brain Tumor Cancer Central Nervous System Diseases Central Nervous System Neoplasms Childhood Cancer Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Nervous System Diseases Nervous System Neoplasms Sarcoma

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Medical Sociology

Halle, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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

  2. Self-concept

    Time frame: Within the first month after diagnosis until half a year after intensive treatment

    Self-Description Questionnaire, SDQ

  3. 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)

  4. 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)

  5. Illness perception

    Time frame: Within the first month after diagnosis until half a year after intensive treatment

    Illness Perception Questionnaire, IPQ

  6. Self-efficacy

    Time frame: Within the first month after diagnosis until half a year after intensive treatment

    General Self-Efficacy Scale; SWE

  7. 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

  8. 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)

  9. 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

  10. Coping

    Time frame: Within the first month after diagnosis until half a year after intensive treatment

    Coping Questionnaire for Children and Adolescents, CODI

  11. Mental health

    Time frame: Within the first month after diagnosis until half a year after intensive treatment

    Children's Depression Screener, Child-S

  12. Autonomy

    Time frame: Within the first month after diagnosis until half a year after intensive treatment

    Subscale from The Kidscreen Questionnaire

Other outcomes

  1. 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)

  2. 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)

  3. Evaluation of the treatment

    Time frame: End of intensive treatment

    Questionnaire to assess the Satisfaction with the Treatment, FBB

  4. 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)

  5. Family resources

    Time frame: Within the first month after diagnosis and half a year after intensive treatment

    Family Environment Scale, FES (parental questionnaire)

  6. Satisfaction with life

    Time frame: Within the first month after diagnosis until half a year after intensive treatment

    The Satisfaction With Life Scale, SWL

  7. Doctor-parent relationship

    Time frame: End of intensive treatment

    Patient Reactions Assessment, PRA-D

  8. 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

  9. 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

  10. Mental health

    Time frame: Within the first month after diagnosis until half a year after intensive treatment

    Hospital Anxiety and Depression Scale, HADS

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Registry information

Official study title

Social Inequalities in the Participation and Activity in Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas

Acronym: SUPATEEN

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 24, 2019
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.