Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas

Cancer Clinical Trial

— SUPATEEN  

Official title:

Social Inequalities in the Participation and Activity in Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04101123
• Other study ID #: 70113424
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: October 2021
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: Julia Roick, Dipl.-Soz.
• Phone: 0049-345-5571136
• Email: julia.roick[@]medizin.uni-halle.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 28, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Cancer
• Brain Neoplasms
• Brain Tumor
• Cancer
• Childhood Cancer
• Leukemia
• Sarcoma

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
Germany	Institute of Medical Sociology	Halle (Saale)

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental coping with chronic childhood disease	Coping Health Inventory for Parents, CHIP (parental questionnaire)	Within the first month after diagnosis until half a year after intensive treatment
Other	Psychosocial needs	Short-Form Supportive Care Needs Survey Questionnaire, SCNS-SF34 (parental questionnaire)	Within the first month after diagnosis until the end of intensive treatment
Other	Evaluation of the treatment	Questionnaire to assess the Satisfaction with the Treatment, FBB	End of intensive treatment
Other	Familial burden	Impact on Family Scale in Families with Children with Disabilities, FaBel (parental questionnaire)	End of intensive treatment until half a year after intensive treatment
Other	Family resources	Family Environment Scale, FES (parental questionnaire)	Within the first month after diagnosis and half a year after intensive treatment
Other	Satisfaction with life	The Satisfaction With Life Scale, SWL	Within the first month after diagnosis until half a year after intensive treatment
Other	Doctor-parent relationship	Patient Reactions Assessment, PRA-D	End of intensive treatment
Other	Level of quality of life	The Short Form Health Survey, SF-12	Within the first month after diagnosis until half a year after intensive treatment
Other	Sense of coherence	Sense of Coherence Scale - Leipziger Short Form, SOC-L9	Within the first month after diagnosis until half a year after intensive treatment
Other	Mental health	Hospital Anxiety and Depression Scale, HADS	Within the first month after diagnosis until half a year after intensive treatment
Primary	Social participation and activity	The Child and Adolescent Scale of Participation, CASP	Within the first month after diagnosis until half a year after intensive treatment
Primary	Level of quality of life	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)	Within the first month after diagnosis until half a year after intensive treatment
Secondary	Evaluation of the 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	End of intensive treatment
Secondary	Self-concept	Self-Description Questionnaire, SDQ	Within the first month after diagnosis until half a year after intensive treatment
Secondary	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 Values: range from 0 to 100 (higher values represent higher symptoms of fatigue)	Within the first month after diagnosis until half a year after intensive treatment
Secondary	Social support	Social Support Scale, SSS Values: total score with a range 8-40 (higher values represent higher support)	Within the first month after diagnosis until half a year after intensive treatment
Secondary	Illness perception	Illness Perception Questionnaire, IPQ	Within the first month after diagnosis until half a year after intensive treatment
Secondary	Self-efficacy	General Self-Efficacy Scale; SWE	Within the first month after diagnosis until half a year after intensive treatment
Secondary	Optimism	Subscale from The Bern Subjective Well-Being Questionnaire for Adolescents, BFW	Within the first month after diagnosis until half a year after intensive treatment
Secondary	Psychosocial problems and strengths	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)	Within the first month after diagnosis until half a year after intensive treatment
Secondary	Sense of coherence	Children Sense of Coherence Scale, C-SOC	Within the first month after diagnosis until half a year after intensive treatment
Secondary	Coping	Coping Questionnaire for Children and Adolescents, CODI	Within the first month after diagnosis until half a year after intensive treatment
Secondary	Mental health	Children's Depression Screener, Child-S	Within the first month after diagnosis until half a year after intensive treatment
Secondary	Autonomy	Subscale from The Kidscreen Questionnaire	Within the first month after diagnosis until half a year after intensive treatment