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JOURNAL ONKOLOGIE – STUDIE

SUPATEEN Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas

Rekrutierend

NCT-Nummer:
NCT04101123

Studienbeginn:
Januar 2020

Letztes Update:
28.08.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Leukemia, Sarcoma, Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Martin-Luther-Universität Halle-Wittenberg

Collaborator:
-

Studienleiter

Matthias Richter, Prof. Dr.
Study Chair
Martin-Luther-Universität Halle-Wittenberg

Kontakt

Studienlocations (1 von 1)

Studien-Informationen

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.
 

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Social participation and activity (Time Frame - Within the first month after diagnosis until half a year after intensive treatment):
The Child and Adolescent Scale of Participation, CASP

2. Level of quality of life (Time Frame - 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 outcome:

1. Evaluation of the treatment (Time Frame - 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

2. Self-concept (Time Frame - Within the first month after diagnosis until half a year after intensive treatment):
Self-Description Questionnaire, SDQ

3. Fatigue (Time Frame - 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)

4. Social support (Time Frame - 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)

5. Illness perception (Time Frame - Within the first month after diagnosis until half a year after intensive treatment):
Illness Perception Questionnaire, IPQ

6. Self-efficacy (Time Frame - Within the first month after diagnosis until half a year after intensive treatment):
General Self-Efficacy Scale; SWE

7. Optimism (Time Frame - Within the first month after diagnosis until half a year after intensive treatment):
Subscale from The Bern Subjective Well-Being Questionnaire for Adolescents, BFW

8. Psychosocial problems and strengths (Time Frame - 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)

9. Sense of coherence (Time Frame - Within the first month after diagnosis until half a year after intensive treatment):
Children Sense of Coherence Scale, C-SOC

10. Coping (Time Frame - Within the first month after diagnosis until half a year after intensive treatment):
Coping Questionnaire for Children and Adolescents, CODI

11. Mental health (Time Frame - Within the first month after diagnosis until half a year after intensive treatment):
Children's Depression Screener, Child-S

12. Autonomy (Time Frame - Within the first month after diagnosis until half a year after intensive treatment):
Subscale from The Kidscreen Questionnaire

Geprüfte Regime

  • Non-Interventional:
    Non-Interventional

Quelle: ClinicalTrials.gov


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