Clinical trial NCT02808520: Social Inequalities in the Participation and Activity in Children and Adolescents With Hodgkin-lymphoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Classical Hodgkin Lymphoma
Keywords: Social participation
Children and adolescents with cancer
Quality of life with hodgkin-lymphoma
Social inequalities and cancer
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: German Cancer Aid
name: University of Giessen
First posted: 2016-06-21
Enrollment: 700
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with hodgkin-lymphoma and their parents

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Social participation
timeFrame: one month after diagnosis until two years
measure: Quality of life
timeFrame: one month after diagnosis until two years
Secondary outcomes:
measure: Understanding of illness
timeFrame: one month after diagnosis until two years
measure: Autonomy
timeFrame: one month after diagnosis until two years
measure: Self-efficacy
timeFrame: one month after diagnosis until two years
measure: Optimism
timeFrame: one month after diagnosis until two years
measure: Coping
timeFrame: one month after diagnosis until two years
measure: Sense of coherence
timeFrame: one month after diagnosis until two years
measure: Behavioural disorders and strengths
timeFrame: one month after diagnosis until two years
measure: Fatigue
timeFrame: one month after diagnosis until two years
measure: Satisfaction with treatment
timeFrame: one month after diagnosis until two years
measure: Social support
timeFrame: one month after diagnosis until two years
Other outcomes:
measure: Parental coping with chronic childhood disease
timeFrame: one month after diagnosis until two years
measure: Consequences of chronic conditions and disability in childhood and adolescence for the family
timeFrame: one month after diagnosis until two years
measure: Family atmosphere
timeFrame: one month after diagnosis until two years
measure: Psychosocial needs
timeFrame: one month after diagnosis until two years
measure: Use of psychosocial care services
timeFrame: one month after diagnosis until two years
measure: Satisfaction with treatment
timeFrame: one month after diagnosis until two years
Locations:
Study officials:
affiliation: Institute of Medical Sociology, Martin Luther University Halle-Wittenberg
name: Matthias Richter, Prof. PhD
role: STUDY_CHAIR
affiliation: Center for Pediatrics and Adolescent Medicine, Justus-Liebig University of Giessen
name: Dieter Körholz, Prof. MD
role: STUDY_CHAIR
References: