Social Inequalities in the Participation and Activity in Children and Adolescents With Hodgkin-lymphoma

Study Overview
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Brief Summary
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Purpose of this study is to determine the influence of social factors on participation and activity among children and adolescents aged 10-18 years with hodgkin-lymphoma. Furthermore personal and treatment-related factors and their impact on participation will be explored.

Detailed Description
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Hodgkin-lymphoma is a rare malignancy among children and adolescents (about 140 each year in Germany) which is highly curable. Beside this therapeutic success, a lot of therapy-related long-term problems arise (e.g. fertility disorders, thyroid diseases, secondary malignancies). While most of the studies focused on mental and physical impairments, little attention has been drawn to social dimensions of health. Due to the disease and the requirements of the therapy, participation of children with hodgkin-lymphoma can be impaired acutely or chronically. This can be of serious consequences, because participation in daily life is an important component of the development of children and adolescents. To determine the influence of social, personal and treatment-related factors on participation, all patients who were actual treated in the international therapy study EuroNet-PHL-C2 in all of Germany (N ≈ 700) and their parents will be interviewed. Statistical analyses will be done using descriptive and multivariate methods taking account of treatment-related issues (e.g. stage of disease, chemotherapy, radiotherapy, progression/relapse).

Official Title
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Social Inequalities in the Participation and Activity in Children and Adolescents With Hodgkin-lymphoma. A Prospective Multicenter Cohort Study of Social and Personal Influencing Factors

Conditions
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Classical Hodgkin Lymphoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed primary diagnosis of classical Hodgkin's Lymphoma 10-18 years written informed consent of the patient and/or the patient's parents or guardian according to national laws Exclusion Criteria: other (simultaneous) malignancies

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hodgkin-lymphoma<br>Children and adolescents aged 10-18 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social participation | The Child and Adolescent Scale of Participation, CASP | one month after diagnosis until two years | 
| Quality of life | Questionnaire to assess Health Related Quality of Life in chronically ill Children and Adolescents, KINDL | one month after diagnosis until two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding of illness | Illness Perception Questionnaire, IPQ | one month after diagnosis until two years | 
| Autonomy | Subscale Autonomy from the Health-Related Quality of Life Questionnaire for Children and Adolescents, Kidscreen | one month after diagnosis until two years | 
| Self-efficacy | Self-Efficacy for Managing Chronic Disease 6-Item Scale, SES6 | one month after diagnosis until two years | 
| Optimism | Subscale from The Bern Subjective Well-Being Questionnaire for Adolescents, BFW | one month after diagnosis until two years | 
| Coping | Coping Questionnaire for Children and Adolescents, CODI | one month after diagnosis until two years | 
| Sense of coherence | Children Sense of Coherence Scale, C-SOC | one month after diagnosis until two years | 
| Behavioural disorders and strengths | Strengths and Difficulties Questionnaire, SDQ | one month after diagnosis until two years | 
| 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 | one month after diagnosis until two years | 
| Satisfaction with treatment | Questionnaire to assess the Satisfaction with the Treatment, FBB | one month after diagnosis until two years | 
| Social support | Social Support Scale, SSS | one month after diagnosis until two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social participation, Children and adolescents with cancer, Quality of life with hodgkin-lymphoma, Social inequalities and cancer