Adolescent Cancer, Brain Tumor, Cancer, Childhood Cancer, Leukemia, Sarcoma
Conditions
Keywords
Social inequalities, Social dimensions of health, Brain tumors, Leukemia, Sarcomas, Childhood Cancer, Children and adolescents with cancer
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.
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Self-concept | Within the first month after diagnosis until half a year after intensive treatment | Self-Description Questionnaire, SDQ |
| 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) |
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Familial burden | End of intensive treatment until half a year after intensive treatment | Impact on Family Scale in Families with Children with Disabilities, FaBel (parental questionnaire) |
| Family resources | Within the first month after diagnosis and half a year after intensive treatment | Family Environment Scale, FES (parental questionnaire) |
| Satisfaction with life | Within the first month after diagnosis until half a year after intensive treatment | The Satisfaction With Life Scale, SWL |
| Doctor-parent relationship | End of intensive treatment | Patient Reactions Assessment, PRA-D |
| Level of quality of life | Within the first month after diagnosis until half a year after intensive treatment | The Short Form Health Survey, SF-12 |
| Sense of coherence | Within the first month after diagnosis until half a year after intensive treatment | Sense of Coherence Scale - Leipziger Short Form, SOC-L9 |
| Mental health | Within the first month after diagnosis until half a year after intensive treatment | Hospital Anxiety and Depression Scale, HADS |
| Psychosocial needs | Within the first month after diagnosis until the end of intensive treatment | Short-Form Supportive Care Needs Survey Questionnaire, SCNS-SF34 (parental questionnaire) |
| Evaluation of the treatment | End of intensive treatment | Questionnaire to assess the Satisfaction with the Treatment, FBB |
| Parental coping with chronic childhood disease | Within the first month after diagnosis until half a year after intensive treatment | Coping Health Inventory for Parents, CHIP (parental questionnaire) |
Countries
Germany
Outcome results
None listed