Clinical trial NCT04101123: Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas
Official title: Social Inequalities in the Participation and Activity in Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Brain Tumor
Sarcoma
Childhood Cancer
Cancer
Adolescent Cancer
Keywords: Social inequalities
Social dimensions of health
Brain tumors
Leukemia
Sarcomas
Childhood Cancer
Children and adolescents with cancer
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 68
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 leukemia, brain tumors, and sarcomas who are between 10 to 18 years old and their parents

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.

Eligibility criteria: 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

Primary outcomes:
measure: Social participation and activity
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Level of quality of life
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
Secondary outcomes:
measure: Evaluation of the treatment
timeFrame: End of intensive treatment
measure: Self-concept
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Fatigue
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Social support
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Illness perception
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Self-efficacy
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Optimism
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Psychosocial problems and strengths
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Sense of coherence
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Coping
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Mental health
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Autonomy
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
Other outcomes:
measure: Parental coping with chronic childhood disease
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Psychosocial needs
timeFrame: Within the first month after diagnosis until the end of intensive treatment
measure: Evaluation of the treatment
timeFrame: End of intensive treatment
measure: Familial burden
timeFrame: End of intensive treatment until half a year after intensive treatment
measure: Family resources
timeFrame: Within the first month after diagnosis and half a year after intensive treatment
measure: Satisfaction with life
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Doctor-parent relationship
timeFrame: End of intensive treatment
measure: Level of quality of life
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Sense of coherence
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
measure: Mental health
timeFrame: Within the first month after diagnosis until half a year after intensive treatment
Locations:
city: Halle (Saale)
country: Germany
facility: Institute of Medical Sociology
Study officials:
affiliation: Martin-Luther-Universität Halle-Wittenberg
name: Matthias Richter, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Roick J, Berner R, Bernig T, Erdlenbruch B, Escherich G, Faber J, Klein C, Bochennek K, Kratz C, Kuhr J, Langler A, Lode HN, Metzler M, Muller H, Reinhardt D, Sauerbrey A, Schepper F, Scheurlen W, Schneider D, Schwabe GC, Richter M. Social inequalities in the participation and activity of children and adolescents with leukemia, brain tumors, and sarcomas (SUPATEEN): a protocol for a multicenter longitudinal prospective observational study. BMC Pediatr. 2020 Jan 31;20(1):48. doi: 10.1186/s12887-020-1943-3.