Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas
- Conditions
- Adolescent CancerCancerLeukemiaBrain TumorSarcomaChildhood Cancer
- Interventions
- Other: Non-Interventional
- Registration Number
- NCT04101123
- Lead Sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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
- having a relapse or secondary tumor
- insufficient command of German
- profound cognitive and physical impairments
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children and adolescents with cancer Non-Interventional Children and adolescents between 10-18 years with newly diagnosed leukemia, brain tumors, and sarcomas
- Primary Outcome Measures
Name Time Method Level of quality of life 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)
Social participation and activity Within the first month after diagnosis until half a year after intensive treatment The Child and Adolescent Scale of Participation, CASP
- Secondary Outcome Measures
Name Time Method Self-concept Within the first month after diagnosis until half a year after intensive treatment Self-Description Questionnaire, SDQ
Evaluation of the treatment 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
Illness perception Within the first month after diagnosis until half a year after intensive treatment Illness Perception Questionnaire, IPQ
Self-efficacy Within the first month after diagnosis until half a year after intensive treatment General Self-Efficacy Scale; SWE
Optimism Within the first month after diagnosis until half a year after intensive treatment Subscale from The Bern Subjective Well-Being Questionnaire for Adolescents, BFW
Psychosocial problems and strengths 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)
Sense of coherence Within the first month after diagnosis until half a year after intensive treatment Children Sense of Coherence Scale, C-SOC
Social support 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)
Fatigue 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)
Coping Within the first month after diagnosis until half a year after intensive treatment Coping Questionnaire for Children and Adolescents, CODI
Mental health Within the first month after diagnosis until half a year after intensive treatment Children's Depression Screener, Child-S
Autonomy Within the first month after diagnosis until half a year after intensive treatment Subscale from The Kidscreen Questionnaire
Trial Locations
- Locations (1)
Institute of Medical Sociology
🇩🇪Halle (Saale), Germany